Device and method for filling an aneurysm or body cavity

ABSTRACT

The invention relates generally to embolic agents and embolic delivery systems more specifically it relates to a device and method for filling of aneurysm or body cavity. In various embodiments, segmented and monolithic embolic agents provide the operator with the ability to select and detach the length of embolic agent, either extracorporeally or intracorporeally as desired by the operator, for implantation into the aneurysm or body cavity. Linking elements and detachment elements may be utilized by the operator to connect and detach variable lengths of embolic agents either extracorporeally or intracorporeally utilizing electrolytic, chemical, and mechanical detachment mechanisms. Embolic delivery systems are disclosed providing for constant and steady propulsion of the embolic agent.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/887,777, filed May 6, 2013 which claims the benefit of U.S.provisional patent application Ser. No. 61/642,762, filed on May 4, 2012and application Ser. No. 13/887,777 claims the benefit of provisionalpatent application Ser. No. 61/660,930, filed on Jun. 18, 2012, whichare all hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to embolic materials and morespecifically it relates to a device and method for filling of ananeurysm or body cavity. The purpose of this invention is to provide adevice and method for filling of a small or large aneurysm or other bodycavity with material to prevent flow of blood or bodily fluids andpromote blood clot or scarring in the tissues to prevent undesirableconditions such as bleeding or fluid leakage.

BRIEF SUMMARY OF THE INVENTION

The invention generally relates to an embolic material and method forits delivery into the body. The elements of the invention in the variousdescribed embodiments may include an introducer sheath, an introducercatheter, a microcatheter, an embolic agent, a linking element, adetachment element, an embolic delivery apparatus, an emboliccontainment apparatus, a guide wire, a pusher element, tractionelements, a stopcock, a side port adaptor, embolic detachment tools, andin certain environments an endograft or stent. The operator selects theelements of the invention as necessary to perform the procedure as maybe required.

In one embodiment, the invention comprises a device and method forfilling of a small or large aneurysm or other body cavity with materialto prevent flow of blood or bodily fluids and promote blood clot orscarring in the tissues to prevent undesirable conditions such asbleeding or fluid leakage. In one embodiment, the invention comprises adevice and method for filling of an aneurysm or body cavity that may beused for many sizes of aneurysm or cavity, including very large onesthat may be difficult or impossible to treat with other means or withconventional embolic agents.

In one embodiment, the invention comprises a device and method forfilling of an aneurysm or body cavity that provides rapid filling of theaneurysm or cavity that might otherwise take substantially more time tofill or to prevent flow of body fluids or blood using other means. Inone embodiment, the invention comprises a device and method for fillingof an aneurysm or body cavity with a high degree of safety due to smallinstrument sizes and use of embolic materials that are biocompatible andmay be accurately delivered to target tissue without inadvertentdelivery to non-target tissues. Smaller diameters may be possible due tothe longer lengths of embolic agent possible with this invention,resulting in great volume despite small diameter.

In one embodiment, the invention comprises a mechanical and/or hydraulicmeans of advancement of embolic agent(s) through introducer cathetersthat provide more rapid and controlled deliveries that are not currentlypossible with current conventional delivery means and to enable theadvancement of very flexible embolic agents that might be difficult topush manually due to kinking. An object of this invention is to providesuch a delivery means to advance a very long single embolic agent withspeed and control and another object of other embodiments of thisinvention provide a means for very rapid and controlled delivery andadvancement of a great plurality of shorter or more conventionallyproportioned embolic agents in order to provide a great bulk of embolicmaterial in their summation.

In one embodiment, the invention comprises a means of providing a verylong strand of embolic agent which may be reduced in its length duringthe operative procedure using safe and effective means, giving theoperator flexibility to utilize the advantages of a very long singleembolic agent while also having the advantage of tailoring the length toa very specific desired length, with the determination of the desiredlength being possible after the procedure has already begun andconsiderable length of embolic material has already been deployed intothe affected tissues.

In one embodiment, the invention comprises an electrolytic method ofdetaching and shortening the embolic agent during the procedure at oneof many possible locations along the embolic agent instead of beinglimited to one specific detachment location or point as with currentconventional electrolytic agents. In one embodiment, the inventioncomprises an introducer catheter with electrical means to facilitatedetachment or shortening of the embolic agent at or near the tip of theintroducer catheter deep within the body of the subject in.

In one embodiment, the invention provides precision control of theposition of the embolic agent deep within the body of the subject bymanipulation of attached parts accessible to the operators handsextra-corporeally, with ability to advance or retract until the time ofdetachment. In one embodiment, the invention comprises embolic agentsthat are modifiable by the operator to facilitate objectives ofdetermination of total length and location of detachment. In oneembodiment, the invention provides the means to enable electrolyticmethods with greater utility than other known systems by beingapplicable to variable-length embolic agents and also directed to aspecific detachment area. In one embodiment, the invention comprisesmeans to enhance the utility of existing mechanical detachmentconfigurations to be compatible with a variable-length embolic agent.

In this respect, before explaining the invention in detail, it is to beunderstood that the invention is not limited in its application to thedetails of construction or to the arrangements of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments and of being practiced andcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein are for the purpose of thedescription and should not be regarded as limiting. To theaccomplishment of the above and related objects, this invention may beembodied in the form illustrated in the accompanying drawings, attentionbeing called to the fact, however, that the drawings are illustrativeonly, and that changes may be made in the specific constructionillustrated and described within the scope of this application.

BRIEF DESCRIPTION OF THE DRAWINGS

Various other objects, features and attendant advantages of the presentinvention will become fully appreciated as the same becomes betterunderstood when considered in conjunction with the accompanyingdrawings, in which like reference characters designate the same orsimilar parts throughout the several views, and wherein:

FIGS. 1A-C are simplified block diagrams in the front view illustratingthe overall elements for embolization in one embodiment of the presentinvention;

FIGS. 1D-L are schematic representations of different categories ofdetachment systems including conventional and novel;

FIGS. 1M-N are schematic demonstrations of the limitations ofconventional systems for treatment of large cavities, and the advantagesof the novel systems disclosed herein;

depict various novel embolic agents according to the various embodimentsof the disclosed invention;

FIGS. 2A-S illustrate different types of novel embolic agents in variousembodiments of the disclosed invention;

FIGS. 3A-J depict various connection and delivery configurations of theembolic agents and catheter embodiments of the disclosed invention;

FIGS. 4A-C show threaded embodiments of the novel embolic agentsdisclosed herein;

FIGS. 5A-M depict various embodiments of the novel embolic agents withradiomarkers as disclosed herein and which may be sized and detachedintra-corporeally as disclosed herein;

FIGS. 6A-Y show further embodiments of the novel embolic agents whichmay be sized and detached intra-corporeally using electrolytic means asdisclosed herein;

FIGS. 7A-8R depict various embodiments of novel embolic agents andapparatus and means for detaching embolic agents using predominantlymechanical or hydraulic means;

FIGS. 9A-G depict novel linking elements and their use to provide forshortening and detachment of embolic agents;

FIG. 10A show an embodiment of a novel chemical embolic agent detachmentsystem as disclosed herein;

FIG. 11A depicts various embodiments of conventional mechanicaldetachment elements which may be employed in novel manner using linkingelements and detachment mechanisms as described herein;

FIGS. 11B-C heat sensitive glue detachment mechanism adapted in novelmanner with linking element to provide for ability to shorten embolicagent or choose detachment point;

FIGS. 12A-H depict various embodiments of novel catheters containingelectrical elements comprising two electrodes which are utilized inconjunction with the embolic agents and embolic delivery systems toprovide for electrolytic detachment as described herein;

FIG. 12I depicts a novel catheter containing electrical elementscomprising two electrodes and embolic agents whereby non-electrolyticelectrical means provide detachment of embolic agent;

FIG. 12J depicts various embodiments of embolic agents useful to someembodiments of the delivery system as described herein;

FIGS. 13A-F depict various embodiments of novel introducer catheterscontaining electrical elements comprising one electrode which areutilized in conjunction with the embolic agents and embolic deliverysystems described herein;

FIGS. 14A-B depict various embodiments of variations of use ofelectrical systems to provide detachment as described herein;

FIGS. 15A-B depict various embodiments of venting catheters which areutilized in conjunction with the embolic agents and embolic deliverysystems described herein;

FIGS. 16A-17 show an embodiment of a novel embolic delivery systempropelling the embolic agent using feeder wheels or belts as describedherein;

FIGS. 18A-M show various embodiments of traction elements which may beformed or fashioned on to or within embolic agents as described herein;

FIGS. 19A-E and FIGS. 20A-H depict various embodiments of novel tractionelements as described herein;

FIGS. 21A-F depict various embodiments of novel traction elements andpusher elements as described herein;

FIGS. 22A-H depict various embodiments of embolic delivery systems thatutilize a principle of an attached flexible member such as a string orfilament or tape that may be pulled to force an embolic agent through acatheter and then are stripped away from the agent in a running manner,as disclosed in various embodiments of the invention;

FIGS. 23A-I show various embodiments of novel embolic delivery systemsthat use bidirectional linear motion elements combined with tractionelements to provide uni-directional linear motion of embolic agents asdescribed herein;

FIGS. 24A-G depicts embodiments of a novel embolic delivery system thatcombines a linear feeding mechanism with a revolving mechanism toprovide rapid sequential delivery of a plurality of embolic agents ofshort or medium length as described herein;

FIGS. 25A-C depict embodiments of a novel embolic delivery system usinga non-revolving mechanism to provide rapid sequential delivery of aplurality of embolic agents of short or medium length as describedherein;

FIGS. 26A-G depict various embodiments of tools providing formodification of an embolic agent intra-procedurally as described herein;

FIG. 27A-B depict embodiments of introducer elements and adaptors whichmay be used in connection with invention disclosed herein;

FIGS. 28A-D depict various embodiments of novel embolic agents withshape memory features useful to some embodiments of delivery system asdescribed herein.

DETAILED DESCRIPTION OF THE INVENTION

Before proceeding with a detailed description of the invention, somecommonly used terms will be defined to aid the reader in theunderstanding and practice of the invention disclosed herein.

The introducer sheath is a hollow tube of semi-rigid material with athin wall. It permits introduction of other elements described belowinto the body. The other elements, such as the introducer catheter, maypass through the lumen, or hollow core, of the introducer sheath. Thetip of the introducer sheath will usually be positioned inside the body,such as in the artery in FIG. 1, while the proximal end will usually beoutside the body. Once it is in position, it may be left in place formost of the procedure, and thus provides a channel for passage ofinstruments from the outside to the inside of the body. Severalintroducer sheaths may be in place at one time, and some may be used forpassage of instruments that are not part of this invention, as well asfor instruments composing this invention. Introducer sheaths areconventional elements known in the art. An introducer catheter may beused without an introducer sheath in some instances.

The introducer catheter is a hollow shaft of semi-rigid material with athin wall, but is generally longer in length than an introducer sheathand often smaller in caliber so that it can fit co-axially inside anintroducer sheath. It may be manipulated by a user or operator into thedesired part of the body, often under fluoroscopic imaging for guidance.In FIG. 1 it is seen to have its distal tip inside the body in an aorticaneurysm, and can be seen to be in close proximity and adjacent to theendograft inside the body aneurysm, but does not pass inside the hollowendograft. It may be passed over a guide wire for more control, and tofacilitate the desired placement. The introducer catheter may be used topass the embolic agent, such as a long filament, from outside the body,into the body where treatment is needed. Although the introducercatheter may enter the body through the introducer sheath, it may alsobe introduced through the tissues without the introducer sheath usingmeans well known in the art. Introducer catheters are conventionalelements commonly used in the art for many purposes including theintroduction of embolic agents. Novel variations are described in thisinvention, including introducer catheters that provide elements andfunctions relating to detachment of the embolic agents as describedbelow, sometimes including electrolytic mechanisms that are partiallylocated within the introducer catheter.

Embolic agents are used in conventional practice of the art, often usingconventional introducer sheaths and introducer catheters. In thisinvention, novel embolic agents are described in detail elsewhereherein. Various embodiments of novel embolic agents are depicted. Theembolic agents described in this invention are solids, and longer in thelongitudinal axis than in width, like strings or wires or filaments ofvarious lengths and widths and shapes depicted in detail elsewhereherein. They may be flexible, but have enough stiffness to be capable ofbeing pushed by a pusher element or embolic delivery system. In FIG. 1,a long, narrow filamentous embolic agent is seen housed in an emboliccontainment apparatus outside of the body, being pushed into anintroducer catheter by an embolic delivery system, and exiting thedistal end of the introducer catheter inside the body; in this exampleinto an aneurysm of the abdominal aorta where it kinks and folds into acomplex shape, thus filling much of the space within the aneurysm cavityin the body. Many details and variations of embolic agents comprise manyof the novel aspects of this invention.

A novel linking element is used by the operator to modify themanufacturer-supplied elements by linking, defined as connectinglinearly (i.e. “end-to-end”), other elements with a non-detachableattachment as seen in FIGS. 1I and 1J. The linking site is separate fromthe detachment site, and is not located on the linking element. Usuallythe elements that are linked by the linking element are the embolicagent (on its proximal aspect) to the detachment element (on its distalaspect) with the result of and end-to-end series of connected elementsthat may be advanced or retracted in unison by operator-manipulation ofthe proximal aspect of the proximal component, i.e. the pusher element.In this invention linking elements are used in conjunction withdetachment elements to enable operator-controlled detachment of theembolic agent from the pusher element. Although linking elements do notdetach, their function provides the operator with the novel ability toapply the detachment element and pusher elements at the location oftheir choice on the embolic agent, thereby enabling the novel aspects ofvariable length as determined by operator after partial completion ofprocedure when ideal final length becomes evident. Concepts of linkingelements are demonstrated in FIGS. 1D-1L.

Detachment elements are elements that provide a detachable attachmentbetween other elements arrayed end-to-end so that one element, usuallyan embolic agent, may be positionally controlled by operatormanipulation of another element, usually the pusher element, until theoperator wishes to separate the detachment element, or separate betweentwo detachment elements which were attached together, thereby separatingthe other two elements from each other, such as the embolic agent fromthe pusher element. There are many different embodiments of previouslydescribed detachment elements, with several commercially available,corresponding to configurations and limitations described in FIGS. 1D-F.The invention disclosed herein additionally describes detachmentelements with configurations and properties described herein. At thetime of manufacture the detachment elements in this invention arenon-detachably attached to the embolic agent and/or the linking orpusher element depending on embodiment.

The embolic delivery systems described herein are machines made of solidmaterials that can withstand wetness without losing function, such asmetal, plastic, and rubber or rubber-like flexible compounds. They mayalso contain electrical components and a motor with speed controls, andan electrical power source such as battery. The system serves to drivethe embolic agent to the target tissue in the body. It may drive theembolic agent though a side port adaptor and then through the throughthe introducer catheter before it reaches the target tissue in the bodyas seen in FIG. 1, although many variations are described herein wheredifferent components and configurations are different to achieve asimilar result of driving the embolic agent to the target tissue. Insome examples described later herein, and as shown in FIG. 1, theembolic delivery system includes a system of pulleys and a toothed belt,whereby the drive system, in this case the hand of the operator, turns ahand crank to drive the large pulley, which in turn drives the feederrollers, which then move the embolic agent. The embolic delivery systemsare all novel elements of this invention, and include many variationsthat include different sub-elements and mechanisms. Also describedherein are embolic delivery systems that utilize hydraulic propulsionmechanisms to drive embolic agents. Also described is system using acombination of feeder rollers and hydraulic mechanisms. Also describedherein are embolic delivery systems that include traction elements and ato-and-fro motion of the driving mechanism, sometimes in combinationwith a clamp, to drive the embolic agent to its target tissue in thebody. The pusher element can be an adjunct to the embolic deliverysystem, and as such can serve to function as an embolic delivery systemor in conjunction with an embolic delivery system. Also described aresystems that provide for rapid sequential delivery of a plurality ofshort or medium length embolic agents.

The pusher element exists in simple forms conventionally in the art, butis described in this invention in novel forms. They are generally a longand narrow, and flexible enough to pass through a catheter with curves,but rigid enough to push an embolic agent through the catheter, such asthe introducer catheter. Such characteristics may be aided bytransitions in stiffness along their length. There are many possiblevariations of pusher elements 90. They may be composed of differentmetals or plastics or other compounds, with varying degrees of stiffnessof the various parts. Some have no transition 95 and are of similarcomposition throughout entire length. Some are helically wound, some aremono-filamentous or mandrel wire composition. This is conventionallymanipulated by the hands of the operator, and is used to push an embolicagent through a catheter into the target area in the body. Conventionalpusher elements are either attached to the embolic agent or notattached. Those that are not attached may push the embolic agent whenboth are constrained within the lumen of a catheter whose inner diameteris roughly similar to the outer diameters of the embolic agent andpusher element, much like a piston pushing another piston through ahollow cylinder. This type may not retract the embolic agent as they arenot connected. Pusher elements that are attached to embolic agents aredetachably attached since the pusher elements are not left inside thebody after use. Before detachment, there two elements are connected andthe embolic agent may be pushed or retracted by manipulation of thepusher element. In novel embodiments of this invention, it may bedetachably or non-detachably connected to the embolic delivery system toaffect the proper movement of the pusher element. The pusher element canbe an adjunct to the embolic delivery system, and as such can serve tofunction as an embolic delivery system or in conjunction with an embolicdelivery system. The pusher element may also contain traction elementsin some novel forms of this invention, which may enable novel functionssuch as application of a to-and-fro motion of the pusher elementresulting in a net forward advancement of the embolic agent, orretraction of the embolic agent effected by manipulation of the pusherelement without a rigid attachment between the two elements.Conventional pusher elements may be the same composition and structureas a guide wire, and in some instances they are interchangeable,although in most instances they will have slightly differentcharacteristics to facilitate their goals

The embolic containment apparatus is a container for the embolic agentto store it and prepare it for delivery into the body. Its structuredepends on the embodiment as described later, and may even be optionalin some embodiments. A simple embolic containment apparatus couldconsist of a solid spool, such as is commonly used to store wire orcable or string, in which case it can be as simple as a cylindricalspool of many different types of materials. A slightly more complexembodiment could include a rigid tank-like container which contains thespool and the filament, as seen in FIG. 1, and allows dispensing of thefilament out through an opening to the embolic delivery system. Thistank could be fluid-tight and contain a solution to bathe the filament,or it could be air filled and not be water tight. Such an embodiment asdepicted in FIG. 1 would be a novel aspect of this invention. Other morecomplex structures such as a Side Port Adaptor may be detachably orpermanently connected to the embolic containment apparatus to allowinjection or aspiration of contents. A simple embodiment could include aconventional bag, such as a plastic bag, which contains a coiled orotherwise compacted embolic agent.

More complex and novel embodiments will be described later herein, andcan include an integration of the elements of the embolic containmentapparatus with the embolic delivery system. For example, a rigidcontainer, similar to a tank, can contain embolic agent in such a manneras to permit hydraulic pressure to force the embolic agent out of thecontainment apparatus and into the introducer catheter or othercomponent that will lead to the goal of ultimate delivery of embolicagent to the target tissue in the body. Another embodiment also involvesan integration of the embolic containment apparatus with the embolicdelivery system, and utilizes a solid plunger or piston to force theembolic agent out of the embolic containment apparatus for purposesdescribed above. In some embodiments, the embolic delivery systems andthe embolic containment apparatus are integrated in such a manner thatthe mechanical driver, for example the feeder rollers of the embolicdelivery systems, are housed within the embolic containment apparatus,where they may be sealed within the fluid-tight system. Many othervariations and combinations of these novel elements are possible. Insome embodiments the embolic containment apparatus is fluid-tight, butin others it is not. It is usually rigid in most embodiments, but couldalso be flexible in some embodiments where rigidity is not necessary.The embolic containment apparatus and its variations are novel aspectsof this invention.

A side port adaptor is a conventional device used commonly in the art.It is usually rigid and composed of plastic or metal, has one or morelumens, or channels that extends from one end along its longitudinalaxis, to the other end, permitting flow of a fluid through them. Itoften has connector hubs on both ends that may detachably ornon-detachably connect to another device such as an introducer catheterand/or an embolic delivery system or embolic containment apparatus. Suchconnections are usually fluid-tight. The side port adaptor also includesa side port that also contains one or more lumens that permit a 3-waycommunication of the lumens with the other ports.

A stop cock is a conventional device commonly used in the art, which iscomposed of a rigid material, usually plastic or metal, that has one ormore lumens, 2 or more ports that communicate via the lumen, and ahandle or switch mechanism that permits flow or restriction of flowthrough the lumens. Thus flow of fluid into or out of any port iscontrollable by the operator by manipulating the switch. The ports maybe connected to other devices such as introducer catheter or embolicdelivery system to permit or restrict flow of fluids or embolic agentbetween them. The stopcock is usually fluid-tight, not permittingleakage of contents to the environment, when the ports are attached toother components, or when the switch mechanism is configured to restrictflow.

The embolic detachment tools function to detach or fragment the embolicagent to separate the portion intended to be delivered to the targettissue inside the body from the portion to remain unused outside of thebody. There are many variations of possible embolic detachment toolssome of which are simple, conventional devices such as a common pair ofscissors seen in FIG. 1, or a knife blade, whereas others are noveldevices specific to this invention. Some examples score the embolicagent, or alter it in ways that permit its fragmentation and deploymentas described in more detail elsewhere herein. More complex embolicdetachment tools may include hydraulic means as described elsewhereherein, melting devices, hot wires or burners, spark generators,sanders, shapers, wire strippers, dissolution chamber (where a solventis used to dissolve an element), swaging tools, adhesives, embolic agentmodification tools, electricity sources such as a battery, and heatchambers that provide heat within a specific range. In some variations,the embolic detachment tool is attached to another component such as theintroducer catheter, so that it can detach the embolic agent in alocation remote from the operator, and/or outside of the body. Forexample it could be integrated with the distal end or tip of theintroducer catheter. The embolic detachment tool may also include amethod for detachment that is mostly accomplished by the Operator usinghis hands, such as weakening techniques that utilize manipulations suchas bending or twisting that may be followed by rapid pulling or kinkingto enable detachment.

Traction Elements provide traction or friction to various elements ofthe invention to enable an engagement of the members such that motion ofone member, possibly effected by the operator or embolic delivery systemwill subsequently effect a desired motion, in a desired direction, ofanother member. An example is the presence of traction elements on anembolic agent such as a filament, which engage the traction elements onanother member, such as a pusher element, so that manipulation of thepusher element by the operator will direct the embolic agent through anintroducer catheter into the target tissues in the body. Tractionelements have many different possible shapes and compositions includingthose described in more detail elsewhere herein for embolic agents. Theyare rigid or semi-rigid. Some function by using friction combined withmechanical elements creating a slidable engagement between the twomembers allowing them to move in relation to each other when desired,whereas others create a stronger mechanical engagement where relationalmotion between the two engaged members is very restricted, so that theymove in unison, until they are disengaged. Traction elements formattachments that vary from easily detachable to substantiallynon-detachable. Some traction elements or their manner of use are novelaspects of this invention.

Guide wires are conventional elements, shaped as a long, narrow,semi-rigid elements that fit within the lumens of catheters, introducercatheters, introducer sheaths, or other elements. It may be used to helpguide the other element to its target, or stabilize it, or hold anestablished path for passage of an element later. Ideally, the guidewire is stiff enough to perform the above functions, yet flexible enoughto move forward around curves, and to prevent damage to tissues in thebody.

Guide wires are usually composed of metals such as stainless steel,nickel-titanium alloys, platinum, or gold, among others, and often havea coating of other substances such as a hydrophilic polymer or othernon-metallic compound to provide the desired coefficient of friction andreduction of tendency to induce blood clots when in contact with bloodwithin the patient body.

There are many possible variations of guide wires. They may be composedof different metals or plastics or other compounds, with varying degreesof stiffness of the various parts. Some have no transition and are ofsimilar composition throughout entire length. Some are braided, some aremono-filamentous or mandrel composition. The guide wire may be the samecomposition and structure as a pusher element, and in some instancesthey are interchangeable, although in most instances they will haveslightly different characteristics to facilitate their goals. Many typesof guide wire and pusher elements are commonly used in the art. In thisinvention, guide wires may have many different functions. It can beadvanced through the lumen of catheter into the desired location insidethe body, and then facilitate the passage of the catheter to its desiredlocation, and then withdrawn to permit the use of the lumen for passageof fluids or embolic agent or other materials. It may be used tomaintain a pathway that has been achieved through many elements such asstop cock, introducer catheter, side port adaptor, embolic deliverysystem, and others, so that a catheter or other agent may be passed overit co-axially (guide wire inside lumen of agent), to its desiredlocation. After passing through these elements, it may then pass intothe body, and therefore maintain a path through the elements outside thebody to the target area inside the body.

An endograft is a conventional element, typically composed of one ormore tubes composing wide-caliber lumens that permit the flow of blood,with a wall that prevents blood from passing anywhere except the lumens.It may be a simple tube with one lumen and 2 open ends that permit flowof blood in one end and out the other, or it may be more complex, suchas the commonly used shape of a Y, or upside-down Y, where two tubesjoin to one tube, and their lumens join, so that blood may flow into orout of 3 separate lumen openings at the ends, as seen in FIG. 1. Theendograft is often composed of a metal skeleton for support, whichresults in a flexible structure than could stand on its own, but maypass around corners and bends in the body. Integrated with the metalskeleton is usually a fabric wall made of woven polyester or expandedpolytetrafluoroethylene. The endograft is usually inserted into thepatient's body through a catheter that is inserted into an artery, in acompacted form that reduces its diameter considerably to permit passagethrough a much smaller hole than its ultimate fully expanded diameterwill become after deployment. Once deployed, it is allowed to open toits full diameter, and attach to the inside of the vessel by variousmeans such as hooks or friction. It will then permit flow of bloodthrough its lumens, but not through its wall, thus preventing flow intoabnormal structures such as an aneurysm in the patient's body as seen inFIG. 1.

Detachment mechanisms provide a detachable attachment between an embolicagent and a pusher element or something that functions as a pusherelement, possible with other elements in a line, said pusher remainingpartially within the operating field where the operator may manipulateit, providing control of the embolic agent indirectly, which may be deepwithin the body beyond the reach of the operator during crucialprocedural steps. Electrolytic detachment of embolic agents is aprinciple and technique used in conventional embolic systems wherebyelectrical current is passed through components and ionic fluid mediumor blood in a manner that takes advantage of well described electrolyticeffect of corrosion of a metallic component of the circuit. Thecorrosion leads to disintegration of a segment of the wire-shapedstructure, which then results in disconnection, fragmentation, ordetachment, of the two newly separated components. The configuration ofpolarity will determine the type of electrochemical reaction that occursand the desired effects of corrosion of the detachment element. Thechoice of metals determines the results as well. Stainless steel is acommon metal in medical products which is susceptible to rapidelectrolytic corrosion and is utilized in this invention. NickelTitanium alloys are used as well. “Non-corrodible” metals are referredto in this document for simplification, but may actually be minimally orslowly corrodible to degrees that are not significant when used in themanners described herein. A common example of this is platinum, which iscommonly used in medical devices due to this effect as well as itsmalleability, flexibility, and X-ray density. Some embodiments of theembolic agent in this invention utilize electrolysis to enable precisepositioning of the distal portion of the embolic agent within the body,to enable the operator to choose the total length of the embolic agent,and to facilitate the pushing of the embolic agent to the desiredendpoint by allowing it to remain continuous until in final position,and then fragmented, and then proximal portion removed. Most of theelectrolytic systems described herein are novel due to inventionsrequired to enable the desired functions which were not conventionallyavailable. Mechanical detachment systems described herein achievesimilar results as described above but use mechanical means to providethe detachable attachments necessary. Many mechanical systems have beenpreviously described, and herein we disclose new novel systems as wellas novel adaptations of existing detachment components to achieve thenovel functions we describe.

The operator is the specialist trained in the art who performs theprocedure using the elements of this invention for its purpose. Most ofthe relevant manipulations and device controls are performed by thehands of the operator as seen in FIG. 1. The operator's hands aregenerally outside of the patient, since this invention is predominantlyused with techniques that permit passage of materials into the bodythrough small bore elements such as introducer catheter and introducersheath, although it may also be amenable to open techniques, whereby theoperator will perform a larger surgical incision and use her handsand/or other instruments to deploy the embolic agent using some or allof the elements of this invention, in which case the operator's handsand/or some of the elements of this invention will be inside of thebody. In any case these devices must enable delicate control of theelements deep within the body that are outside of the direct reach ofthe operator, through the other elements that extend into the operator'sfield.

Turning now to the drawings, in which similar reference charactersdenote similar elements throughout the several views, the figuresillustrate the main elements of this invention. Many elements of theinvention are seen in FIG. 1A and include an introducer sheath 240, anintroducer catheter 200, an embolic agent 1, an embolic delivery system324, an embolic containment apparatus 500, a stopcock 560, a side portadaptor 530, an embolic detachment tool 160, an operator 600, a bodycontaining an abnormal cavity or aneurysm 582, and an endograft 570. Theembolic agent 1 is spooled in the embolic containment apparatus 500, andfed by the embolic delivery system 324, which is controlled by theoperator 600, into the side port adaptor 530 which has a stopcock 560 onits side port, then into the introducer catheter 200, which passes intothe body 580 through an introducer sheath 240 that traverses the skinand enters the femoral artery 585. The introducer catheter 200 passes upthe arteries into the abnormal aneurysm 582, which involves the aorta586 in this example. The embolic agent 1 passes through and beyond theintroducer catheter 200 to fill the cavity 581 (aka sac) of the aneurysm582. Embolic detachment tool 160 was used to modify the embolic agent 1prior to completion. FIG. 1B contains main element guide wire 550 whichis shown being used to help pass the introducer catheter 200 into theaneurysm 582 prior to introducing the embolic agent. FIG. 1C shows apusher element 90 being used to advance the final portion of the embolicagent 1 into the aneurysm 582. A linking element 110 and a detachmentelement 120 are seen in line between the pusher element 90 and theembolic agent 1, enabling advancement and retraction of the embolicagent 1 until the operator 600 is satisfied with the position, whendetachment is initiated in the detachment element 120, and then theembolic agent 1 and, in some embodiments, a portion of the detachmentelement 120 is left in the aneurysm 582 and all other components arepulled out. Traction elements are too small to visualize in theseoverview drawings and are used in some embodiments where they aredescribed.

FIGS. 1D-L are longitudinal section schematic views teaching someimportant concepts contrasting the prior art with some of the novelaspects of this invention especially in reference to the embolic agents.The embolic agents 1 and pusher elements 90 are much longer than easilyrepresented so smooth wavy lines are used to represent continuity of theelements. Jagged lines indicate detachment points 132. FIG. 1Drepresents a common conventional embolic agent 1 and pusher element 90commonly referred to as a “pushable” embolic, usually a helically coiledwire. When both elements are in the introducer catheter (not shown)which passes from the extra-corporeal field to the intra-corporealtissues the operator may push the embolic agent deep into the body bypushing the pusher element 90, but they may not retract it once pushed(indicated by the one-way arrow pointing up). If the embolic agent 1goes to a non-desired location in the body, it must remain there becauseit cannot be pulled out or repositioned. The length (“Le”) of theembolic agent 1 is pre-determined by the manufacturer, and is limited bypractical necessity to be relatively short, generally not longer thanapproximately 30 cm. as explained in more detail in FIG. 1M-N. This maylead to use of a great number of embolic agents at great cost and istechnically impractical for large aneurysms. Sometimes embolic agents 1of this type are pushed hydraulically instead of with a pusher element90, e.g. by a syringe 653 which is a commonly used simple device forcreating hydraulic pressure. FIG. 1E is a two part sequence depicting aconventional system that gives the operator the freedom to advance orretract the embolic agent 1 by manipulating the pusher 90 (indicated bybidirectional arrow) because they are securely attached together by adetachment element 120 as on the left. When the embolic 1 is in thedesired position, detachment may be initiated at the detachment point132 as seen on the right, relinquishing control over the embolic agent1. Finally the pusher 90 is removed. This imposes two importantlimitations of conventional agents. The length (“Le”) of the embolicagent 1 must be pre-determined by the manufacturer, and is limited bypractical necessity to be relatively short, generally not longer thanapproximately 30 cm. as explained in more detail in FIGS. 1M-N. FIG. 1Fis a 3 part sequential schematic that represents another conventionalembolic device which involves operator modification during theprocedure. On the left, an embolic agent 1 with a detachment element 120and a pusher element 90 with a mating detachment element 120 areavailable to the operator. In the middle, the operator has modified thedevice in the operating field by attaching the detachment elements 120to each other, and now has bidirectional control over the embolic agent1 indirectly by controlling the pusher element 90. In the final drawing,the embolic agent has been pushed into the body, and the operatordetaches the components at the detachment point 132 between thedetachment elements 120. Note that the detachment point 132 is also thelocation of operator modification, i.e. the joining of the separateelements. The detachment elements are schematically depicted as ascrew-type system to broadly represent any type of reversible mechanicalattachment mechanism described. This configuration is also subject tothe limitations described in FIG. 1E and FIGs. M-N.

FIG. 1G depicts and demonstrates principles of variable,operator-determined length (Le) of embolic agent 1 and the practicalcapacity for lengths that are vastly greater than conventional embolicagents, possibly over a hundred meters in some embodiments, in additionto full operator control over advancement and retraction of embolicagent 1. Such long lengths would not be possible with conventionalagents because the operator cannot possibly predetermine the exactlength that would be needed in such a large cavity, so would have to usemany conventional agents until the endpoint was achieved. As shown inFIG. 1G, embolic agent 1 includes a series of repeating segments 52,each of which includes a detachment element 120. The embolic agent 1 ispushed into the body without a separate pusher element as the operatormay push directly on the embolic agent until the desired amount is inthe body cavity, at which point detachment is initiated at a selecteddetachment point 132. In some embodiments, the detachment point 132 willbe limited to that most proximate to the operator's field of manualmanipulation extra-corporeally, whereas in other embodiments thedetachment element 120 adjacent to, and distal to, said proximatedetachment element 120 may also be used for detachment, and in otherembodiments any detachment point 132 may be chosen for detachment,although usually requiring modification of the desired detachmentelement 120 by the operator prior to passage of said modified detachmentelement 120 to the place of detachment if deep within the body.

FIG. 1H is a sequential view depicting embolic agent 1 that also hasoperator-determined length (Le) of embolic agent 1, and the practicalcapacity for lengths that are vastly greater than conventional agents,in addition to full operator control over advancement and retraction ofembolic agent 1. In addition, embolic agents 1 in this category haveinfinite choices of detachment points 28 without discrete detachmentelements 120 (not shown) in the manufacture-provided embolic agent 1.This is made possible in part by embolic agents 1 that are modifiableextra-corporeally by the operator in the manual operating field. In thesecond drawing, after modification which is schematically shown as fourvertical lines at detachment point 28, the embolic agent 1 remainsintact and the operator retains control over advancement or retractionof the embolic agent 1 by manipulating its trailing portionextra-corporeally. When the desired position of the modified embolicagent 1 is achieved, detachment may be initiated as seen in the thirddrawing at detachment point 28.

FIG. 1I is a sequential view introducing the novel concept ofoperator-controlled linking elements 110 in the extracorporeal operatingfield to provide the functions of operator-determined length (Le) ofembolic agent 1, and practical capacity for lengths that are vastlygreater than conventional embolic agents, in addition to full operatorcontrol over advancement and retraction of embolic agent 1, and thepresence of infinite choices of detachment points 132 without the needfor discrete detachment elements 110 in the manufacture-provided embolicagent 1, with potential manufacturing simplification. Once the desiredlength of embolic agent 1 is determined by the operator, possibly aftermuch of it is already deployed within the body, it may be severed usingtools, with severed end schematically represented as jagged edge. On theleft, the severed embolic agent 1 is not yet linked to the detachmentelement 120 which is already securely attached to the pusher element 90by manufacturer. In the center drawing, the operator has used thelinking element 110 to link the detachment element 110 to the embolicagent 1. The operator now has control over the embolic agent 1 outsideor inside the body by manipulating the extracorporeal aspect of pusherelement 90. When desired position of embolic agent 1 is achieved,detachment at detachment point 132 is initiated as described previously.Because only one detachment element 120 is needed, and because it doesnot need to be manufactured into the embolic agent 1, this categorypermits the use of a very wide variety of detachment element types,including conventional types that have been modified in novel ways tosuit function in this novel manner, thereby greatly expanding theirutility beyond conventional systems. Nearly any described detachmentmechanism which has been thus far restrained to usage in the limitedmanners of FIG. 1D-F may become the basis for novel modifications thatpermit the greatly expanded utility of the novel devices in the categorydescribed in FIG. 1I.

FIG. 1J is a three part sequential view of a category of embolic agents1 and related elements that permit roughly the same functionality asdescribed for FIG. 1I, however in FIG. 1J the linking element 110 ismanufactured as a separate piece, which is used by the operator to linktwo other separate pieces including the severed embolic agent 1, and thepusher element 90 with attached detachment element 120. Once linked, thefunctionality is similar to FIG. 1I. The separate linking element 110seen in FIG. 1J provides some different functionalities that areexplained in more detail for each embodiment herein. FIG. 1K is a threepart sequential view of a category of embolic agents 1 and relatedelements that permit roughly the same functionality as described forFIG. 1I and FIG. 1J. It resembles conventional configuration in FIG. 1Fexcept that in FIG. 1K there is a linking element 110 which isnon-detachably attached to a detachment element 120 by the manufacturerseen on the left. Once linked to the severed embolic agent 1 by theoperator, the functionality is similar to the novel devices in FIG. 1Ior FIG. 1J, with variable, operator-determined length and full controlof embolic agent 1 through manipulation of pusher element 90 in themiddle drawing, which is detached at will as shown on the right. Thedetachment elements are schematically depicted as a screw-type system tobroadly represent any type of reversible mechanical attachment mechanismdescribed FIG. 1L is a 3 part sequential view of another category ofthis invention where on the left is an embolic agent 1 that has beensevered to desired length by the operator, and a detachment element 120non-detachably attached to a pusher element 90. The severed end of theembolic agent 1, with or without further modifications, is detachablyattached by the operator to the detachment element 120 without the needof a linking element, as shown in the center, giving operator control ofembolic agent 1 via pusher element 90. On the right, when desired, thedetachment element 120 and embolic agent 1 are separated at the sameplace as initial attachment not substantially altered relative to beforethey were attached together.

FIGS. 1M-N schematically demonstrate important limitations ofconventional embolic devices and their solution by this invention, anddemonstrate why conventional embolic agents may not be provided in verylong lengths which are possible in this invention. In FIG. 1M, ascenario is depicted which would very frequently arise if a conventionaldetachable embolic agent 1 of the type described in FIG. 1E or FIG. 1Fwere hypothetically manufactured in very long lengths as is possible forour invention. The detachment point 132 is near the end of the assemblyof embolic agent 1 and pusher element 90. The embolic agent 1 has beenpartially deployed into the aneurysm 582 within the body 580, but theendpoint of maximal embolization has been achieved before the detachmentpoint 132 has reached the aneurysm 582. No viable options are nowavailable. The remainder of embolic agent 1 cannot be passed into theaneurysm 582, it cannot be severed or left dangling partially out of theaneurysm 582 or the body 580, and it would be dangerous to remove thegreat length of already deployed embolic agent 1, as well as renderingthe procedure useless. FIG. 1N is a two part sequence that shows howthis invention addresses this type of scenario due its length beingvariable and operator-determined. The operator may decide, based on theprogress of the procedure in real time, where to position the detachmentpoint 132 along the great length of the embolic agent 1, or in someembodiments, to choose from among many possible detachment points 132along the entire embolic agent 1. In this example the operator chose toenable a detachment point 132 at the position shown. The detachmentpoint 132 of the embolic agent 1 is passed into the aneurysm 5982, wheredetachment will occur, followed by the removal of un-needed portionsfrom the body.

FIGS. 2A-6Y depict different inventive embodiments of the embolic agent1 as described herein. The depicted embolic agents 1 are stiff enough topush through the lumen of a catheter, but flexible enough to fold orkink or bend in order to compact into the cavity of the target tissuesuch an aneurysm. They have a proximal end 18 which is the last to enterthe body, or to be detached from the remainder and discarded. There isalso a distal end 19 which is the first to enter the body, and middle 20in between. Their main function is to occupy the cavity to promote adesired biologic effect such as blood clotting, or tissue healing orscarring to permanently fill the space that was once occupied by gas orfluid with clot, or other solid body tissue. The embolic agents 1 may bepushed to their target directly by the hands of the operator outside ofthe proximal end of the introducer catheter, or by the embolic deliverysystem, or may be pushed by a pusher element which is in turn pushed bythe hands or an embolic delivery system.

An embolic agent 1 may be composed of any biocompatible substance thatis capable of becoming filamentous in structure. Possibilities include,but are not limited to:

Polytetrafluoroethylene (PTFE)

Expanded Polytetrafluoroethylene (ePTFE)

Polyester (PET)

Polypropylene (PP)

Polyamind (Nylon)

A fluoropolymer

A polyurethane

Biocompatible Thermoplastic

Metallic wire or thread, such as platinum, stainless steel, gold,nickel-titanium alloy (e.g. “Nitinol”), alloy mixture, or any metal orcombination of metal that provides the column strength necessary to bepushed through the catheter. It may have an attached agent such as wovenpolyester fibers, or any other fiber or fabric that can be attached tothe wire to provide extra bulk and thrombogenicity (help clot theblood). It could be structured as a helical wire or coil, such as theconventional construction of common 0.035 inch diameter angiographicguide wires widely available. This may contain a solid mandrel wire forextra stiffness, or may occur without the mandrel, thus providing a verysoft and flexible, bendable, and nestable wire. An example of such awire could be a wire similar to the common Bentsen 0.035 inch guide wirewith its mandrel removed.

The embolic agent 1 could be constructed from a biodegradable substancesuch as a polyglycolide, a poly L-lactide, a poly DL-lactide, apoly-caprolactone, a copolymer, or others. Embolic agent 1 may comprisemonofilament or multifilament in structure, e.g., braided, woven, oryarn. Its diameter would permit it to fit through a hypo-tube orcatheter capable of being inserted into an artery or cavity, usually,but not exclusively, a diameter in the range of 0.008″ to 0.1.″

Important properties of the embolic agent 1 include the coefficient offriction when dry and in aqueous environment, flexibility, pushability,elastic modulus, stiffness, diameter, tensile strength, and surfaceirregularity, as relates to friction as well as area of thrombogenicsurface exposed to the blood. Also important in some instances is shapememory. The embolic agent 1 may be straight in its resting state, or itmay be coiled or have any type of complexity of multiple curves to forma complicated nest or compact structure. It may be introduced in astraightened form as it is constrained it its packaging or thecatheters, and then assume its resting shape when placed in the targetarea. It may also exhibit thermal memory, meaning that it takes ondifferent shapes when at different temperatures. This could allow it tobe introduced in a relatively straight form, and then more readilycompact into a multiple curved configuration at body temperature oncedeployed at target.

The embolic agent 1 will need to be stiff enough to allow pushing intoand through the catheter without buckling outside of the proximal end ofthe catheter. Once inside the catheter, the embolic agent 1 will occupymost of the lumen diameter, and will therefore be much less prone tobuckling. However it must have enough flexibility to permit nesting andfolding into the aneurysm sac with extensive redundancy, so that a greatlength of it can be deployed and provide replacement of a substantialvolume of the aneurysm, thus providing vast total surface area topromote thrombosis of blood. A braided material may provide an evengreater surface area on a microscopic level. A hydrophilic compound maybe used to keep the wet friction very low.

The embolic agent 1 may be rendered visible on X-ray imaging usingtechniques that are commonly used in the art. If the embolic agent 1 ismetallic, it may be adequately radio-opaque. If it is not, a metallicwire core or stripe may be applied or contained within the embolic agent1 to provide opacity, or opaque markers, such as dense metals such asgold or platinum, may be placed along the embolic agent 1, either on itssurface or imbedded within. The embolic agent 1 may be diffusely ordiscontinuously impregnated with a radio-opaque substance mixed into itscomposition or applied like a film, or layered within, to providevisibility under X-ray. Such substances may include barium or bismuth.The various shapes of embolic agent 1 are further described below. Toenhance the hydraulic and/or mechanical propulsion of the embolic agent1, the shape can be altered in numerous ways, some of which are depictedherein.

FIG. 2A is a perspective view and FIG. 2B is a longitudinal section viewand FIG. 2B-1 is a cross-section view that depicts a simple shape ofembolic agent 1. The embolic agent 1 is a simple elongated cylindricalshape, round in cross section, with a proximal end 18, middle portion20, and distal end 19. Non-depicted variations could include roundedends. In the depicted embodiment, it is a solid and flexiblemonofilament 5, with enough column strength to allow pushing through acatheter, but enough flexibility to bend or coil and fit into spacesmuch smaller than its full length. It may be composed of any of thesubstances listed herein including polymers or metal, or otherbiocompatible substances which provide the above characteristics asdescribed herein. The surface of the embolic agent 1 is substantiallysmooth to reduce friction resistance as it is delivered to the aneurysmor cavity site. FIG. 2C depicts an embolic agent 1 similar to FIG. 2Aexcept its surface is much rougher, imparting different properties whichmay be desirable for handling during the procedure or for biologiceffects once implanted. FIG. 2D shows an embolic agent 1 which iscomposed of many strands 4 grouped together much as a string or rope maybe made from many finer strands 4. Here, the strands 4 are composed ofeven smaller strands which are too small to be visible in the figure,and are grouped into the larger strands 4 that are depicted. Variouscontemplated embodiments would include different types of groupingconfigurations including simple bundling, weaving, braiding, yarnconfiguration, or any other type of pattern that may yield a filamentousembolic agent 1. This embolic agent 1 may have different surface,biological, thrombogenic and physical properties than the simplermono-structure depicted in FIGS. 2A-B.

FIG. 2E is a longitudinal section view and FIG. 2E-1 is a cross-sectionview that shows an embodiment of embolic agent 1 with shapes andcomposition similar to FIG. 2A, however with the addition of nodes 8that are roughly spherical, and have a greater diameter than the rest ofthe embolic agent 1, which is elsewhere constant in diameter with acircular cross section as shown. The nodes 8 can appear at any intervalalong the length of embolic agent 1 and in one example will occur everyX length, where X is shorter than the length of the introducer catheter.Node 8 may act as a piston in a cylinder (for example, the inside lumenof the catheter) where it fits snugly so as to allow hydraulicpropulsion of the embolic agent 1, while allowing fluid to flow aroundthe smaller diameter embolic agent 1 to reach the bead. Node 8 could bemanufactured from any of the materials described in this inventionincluding polymer, plastic, hydrophilic material, metal, or any otherrigid or semi-rigid compound. It may contain dense material, such asplatinum or gold, to provide opacity under X-ray. In anothercontemplated embodiment, the node 8 may not encase the proximal end 18of the monofilament 5 or its variant material, and instead it may bewelded or adherent to the tip of the end of the monofilament 5 orvariant material. The nodes 8 are concentrically located along theembolic agent 1, whereas in the embodiment depicted in frontal view inFIG. 2F and in cross section in FIG. 2F-1, the nodes 8 are eccentricallylocated along the embolic agent 1 in a variation, but with similarfunction. Nodes 8 depicted are roughly spherical, but variations may becylindrical, globular, or slightly amorphous, so long as it's greatestdiameter is similar to the lumen of the introducer catheter, and stillhave the desired hydraulic effect, functioning similarly to a pistonthat results in a substantial seal with the walls of the introducercatheter while still allowing motion through the catheter when hydraulicpressure, or pusher wire, is applied behind it.

FIG. 2G depicts an embodiment of an embolic agent 1 that is suitable forhydraulic injection. It consists of a monofilament 5, which is round incross section, has a proximal end 18, and a distal end 19. Attached tothe proximal end 18 is a node 8, which consists of PTFE in this example.Node 8 is roughly spherical, and in this example surrounds the proximalend 18 of the monofilament 5. Node 8 is the same, or very slightlysmaller, diameter as the introducer catheter 200 (not shown) to be usedwith it, so that the node 8 will function as a piston that is easilymoved by a hydraulic force behind it, as well as by a pusher elementsuch as a wire (not shown) as described elsewhere in this invention. Thepoint of contact between node 8 with the wall of the catheter will bevery short, keeping the friction between them to a minimum. Themonofilament 5 is narrower in diameter than node 8, and hence alsonarrower than the catheter lumen, so it will also slide easily throughthe catheter when hydraulic force is applied to the node. In oneembodiment instead of a monofilament 5, any other type of long andnarrow material for embolic agent 1 described in this invention,including braided filament, wire (mandrel, braided, or wound), with orwithout fiber attachments may be utilized. FIG. 2H is a frontal view ofa variation of FIG. 2G where the node 8 is attached to a helical wire 33similar to that described elsewhere in this invention. In otherrespects, FIG. 2H is similar to FIG. 2G. FIG. 2I is a longitudinalsection view and FIG. 2I-1 and FIG. 2I-2 are cross-section views thatdepict another embodiment of embolic agent 1. Embolic agent 1 is alsocircular in cross-section but has variable diameters throughout itslength as shown. The narrower segments will be referred to as notches 9,between repeating segments 52 of main body 40. In this embodiment, thenotches 9 are simply variations in the diameter of the embolic agent 1and are concentric. This serves a similar function as the nodesdescribed herein. In this embodiment, the larger caliber of the embolicagent 1 may fit snugly into the lumen 209 of the introducer catheter 200(as shown in the different figures herein), to allow hydraulicpropulsion of the embolic agent 1 as fluid pressure is transmitted atthe smaller caliber portions of the notches 9. The notches 9 may alsoserve to make the embolic agent 1 more flexible and compactable. Thelength and diameter of the variable segments 52 and notches 9 couldinclude many variations. This shape might offer advantages inmanufacture, especially if it could be formed from the stretching and/orbiaxial orientation of segments 52 of an embolic agent 1 to produce thenarrower segments 52. FIG. 2J depicts another embodiment of embolicagent 1 which is circular in cross section in its repeating segments 52of main body 40 between notches 9, where the notches 9 are eccentricallypositioned.

FIG. 2K includes two perspective views of an embolic agent 1 withdifferent types of notches 9 than shown above. The top view is a surfaceview and the bottom view shows the same embolic agent 1, depicting theinternal configuration with dashed lines. In this embodiment, embolicagent 1 is a monofilament 5, round in cross-section as seen in FIG.2K-1, with many notches 9, one of which is depicted, between repeatingsegments 52 of monofilament 5. These notches 9 form a circumferentialhood-like protuberance which can be used for hydraulic effect, actinglike pistons within the lumen of the introducer catheter, to help movethe embolic agent 1 through the catheter upon injection of fluid, withthe direction of motion as shown by dotted arrow. This embolic agent 1may be manufactured by cutting a circumferential notch into the filamentby applying the cutting device along the longitudinal axis of theembolic agent 1, thus splitting away the hooded portion from theunderlying portion of the notch 9. A variation could be made by applyinga hooded portion to a filament without cutting into it. FIG. 2L is alongitudinal surface view and FIG. 2L-1 is a cross section viewdepicting a similar embolic agent 1 with non-circumferential notches 9that are cut into the embolic agent 1, perhaps by a blade, betweenrepeating segments 52 of main body 40. These non-circumferential notches9 would not act as sealed pistons, since the cross-sectional shape isnot a circle, however they will create drag that could help propel theembolic agent 1 hydraulically within the catheter lumen when fluid isflowing through it. Various contemplated embodiments of embolic agent 1may include different compositions of material and differentconfigurations of notch 9.

FIGS. 2M-N depict two different embodiments of conventional embolicagents 1 composed of helically wound metal wire 33. FIG. 2M includes asurface view and a cut-away view showing the helically wound wire 33 tobe round in cross section, and with hollow space inside 34. In thisexample, the wire 33 is comprised of wire loops that are not welded orjoined together in any way, imparting a great deal of lateralflexibility if desired. The degrees of flexibility, column strength,tensile strength tendency to unravel, and electrolytic properties may beadjusted by use of various metals as known in the art, diameter of thewire 33 that is wound into the helical shape, and the diameter of theoverall helical shape. In variation, welds or bonds between some of theloops of wire 33 may be created to change its physical properties,generally imparting more stiffness, column strength, and tensilestrength. It may optionally have a mono-filament smaller wire ornon-metallic fiber running through its core, tethered at the ends orother various points by welds (not shown) to change the properties toprovide more stiffness, or to prevent unraveling or stretching. Theembolic agent 1 is depicted as straight, however it may have memoryshape to assume other configurations as described below. Helical wireembolic agents are conventionally available, however are limited inlength to always be shorter than the introducer catheters, usuallysubstantially shorter, in order to be manually pushed with a simplepusher element similar to a conventional guide wire as explained in FIG.1M-N. In this novel invention, the helical wire embolic agent 1 may bevastly longer, many times longer than the introducer catheter, becauseits precise flexibility and handling characteristics, combined with thenovel embolic delivery systems and novel detachment systems describedherein permit feeding of the novel very long embolic agents describedherein. FIG. 2N includes two surface views depicting a conventionalembolic agent 1 containing a helically wound wire 33, seen in restrainedand unrestrained shapes. It has fiber attachments 3 at variousintervals, composed of tufts of very fine strands of woven polyester orother similar fine flexible filament. The top view depicts itstraightened, as when constrained within a catheter (not shown). Thebottom view shows it unconstrained, as when implanted in a cavity.Embolic agent 1 has shape memory, and when unconstrained, it will assumeits pre-determined shape such as the helix depicted, although it couldassume any of many shapes, including linear, or simply conforming to thespace it occupies, since it is flexible. The fiber attachments 3 serveto occupy space within the target tissue or aneurysm, and promote bloodclotting or favorable tissue reaction. Many variations are possiblewhich utilize different shapes or different compositions to similareffect. Any embolic agent described in this invention disclosure maysimilarly have a memory shape other than the depicted shapes that areused to illustrate the important characteristics of each embolic agent.Variations could include many different types of composition of theembolic agent 1 or its fiber attachments 3, and many different sizes andconfigurations.

FIG. 2O is a schematic diagram of several varieties of three dimensionalmemory shapes of embolic agent 1 when unconstrained within a hypo-tubeor catheter. From left to right, the shapes depicted comprise a simplespiral, multiple loops, three-dimensional cage, chaotic nest, and randomcurves. These shapes may apply to many compositions and sizes of embolicagent 1. It is contemplated that a vast variety of different shapes andconfigurations of embolic agent 1 are possible and in keeping with thisinvention.

FIGS. 2P-S are frontal views that depict various embodiments of embolicagent 1. These are departures from the long filamentous shapes describedthus far. These are shorter in length, usually only a few centimeters,and therefore will require serial administration in greater quantitiesto fill abnormal cavities. FIG. 2P depicts an embolic agent 1 with acylindrical shape, solid, having a proximal end 18, a middle 20, and adistal end 19. This is flexible or semi-rigid, and may pass through thelumen of an introducer catheter as described herein. It may be pushed tothe target tissues using mechanical means or hydraulic means describedherein. In this depiction, embolic agent 1 comprises a polymermonofilament, however in many variations it can be composed of anymaterial listed elsewhere herein. As with all embolic agents describedin this invention, variations could also include rounded ends, notches,nodes, hollow lumen, threads, locking mechanism, fiber attachments,memory shape, or a longitudinal slit, as depicted and described indetail elsewhere herein. FIG. 2Q, depicts an agent 1 similar to that inFIG. 2P, but even shorter in length, such that its length is actuallyless than its diameter. It is otherwise similar in composition andfunction to that in FIG. 2P. FIG. 2R depicts a spherical embolic agent 1that is otherwise similar in composition and function to that in FIGS.2P-2Q. FIG. 2S is a sequence view that depicts an embolic agent 1 withfiber attachments 3 of polyester or similar fine biocompatible thread,attached to a solid rigid core 12, intended for use through relativelylarge diameter introducer catheters 200 as conventionally available inthe field. When unconstrained, this embolic agent 1 has roughly theshape of a sphere. When constrained inside the lumen 209 of theintroducer catheter 200, it may elongate slightly, as it compactsoverall in size. Once it is pushed out of the introducer catheter 200into the target tissues, it will expand due to the natural tendency ofthe tuft of curly fiber attachments 3 to expand. This embolic agent 1may be pushed by mechanical or hydraulic forces described herein. Invariation, the core may be more cylindrical, or it may be absent, andinstead the tuft of woven fibers may have integrity of its own, muchlike a conventional cotton ball.

FIG. 3A shows another embolic agent 1 in longitudinal and cross sectionview 3A-1. The embolic agent 1 is little different from the embolicagent shown in FIG. 2O, except that the ends are rounded. Threeindividual embolic agents 1 are shown end-to-end as could occur duringuse inside an introducer catheter 200 (not shown) or other systemelement. The embolic agent 1 has a proximal end 18, a middle 20, and adistal end 19. It is round at all levels in cross-section FIG. 3A-1. Theproximal end 18 is seen abutted against the distal end 19 of theidentical embolic agent 1 below it, and likewise for the third agent onthe bottom. It can be seen that pushing on the bottom embolic agent 1would result in forward motion of the other two if all were containedinside the lumen of an introducer catheter as described herein. It isalso evident that pulling backward, or retracting, the bottom embolicagent 1 would not necessarily pull the other two embolic agents, sincethey are not attached or connected together. This represents a simplesystem for administering many relatively short embolic agents 1 into thetarget tissues through an introducer catheter by loading them into theintroducer catheter 200 and pushing them forward using hydraulic ormechanical means as described herein.

FIG. 3B shows a similar embolic agent 1; however the shape is slightlymore complex. It is also round in cross-section as seen in FIGS. 3B-1and 3B-2 at all levels, but there are different diameters at differentlevels. The proximal end 18 and distal end 19 are larger in diameterthan the middle section 20, and are equal in diameter to each other. Invariation, the transition between different diameters may be moregradual.

FIGS. 3C-D, 3C-1 and 3D-1 are longitudinal and cross sectionalsequential views of more complex embodiments of the embolic agent 1 ofFIG. 3B where interlocking elements are included to provide additionalstability during deployment. Although the specific shapes of theelements in FIGS. 3C-3D are different, the major characteristics aresimilar and will be described together here for both figures. Theembolic agent 1 has a male locking element 24 on its distal end 19, anda corresponding female locking element 25 on its proximal end 18. Themiddle section 20 is solid, and most of the embolic agent 1 is solid,depicted as the solid portion 23, except for the proximal end 18containing the female locking element 25, which is basically a hollowportion 22 that is surrounded by the solid portion that is round incross section on its inner and outer surfaces. The inside and outsidesurfaces of the entire embolic agent 1 at any level are round. On theleft view, two such embolic agents 1 are shown separately, and will cometogether as shown by dashed line where the male locking element 24 ismated with the female locking element 25, comprising the lockingmechanism 10. The locking mechanism 10 will typically be intended to fitsnugly, but not tightly, so that pulling the proximal embolic agent 1downward will not necessarily pull the distal embolic agent with it.Likewise, advancement of the distal embolic agent 1 will not necessarilyadvance the lower one, which could be left behind. The locking mechanism10 may facilitate the passage of a series of multiple embolic agents 1,which can be very numerous in number, in a smooth manner, throughvarious elements of the system including the introducer catheter (notshown), embolic delivery system (not shown), their connections, and anyothers. They will tend to stay lined up as desired when passing throughareas where they are not circumferentially constrained. At any time,they may be easily disengaged by being pulled apart.

FIGS. 3E-I depict embodiments of embolic agent 1 which is hollow, andtherefore has a tube-like general configuration. As with other embolicagents described herein, this embolic agent 1 has a configuration andcomposition that permits its introduction into target tissues usingembolic delivery systems 324 described herein. Instead of a solid core,it includes a hollow lumen 7. Its composition could be of any of thesubstances described elsewhere herein for embolic agents. Similar hollowtubes exist in the art for purposes such as micro-catheters that aredesigned to allow delivery of fluids or small particles to targettissues. In this invention, the tube is adapted in novel ways to serveas an embolic agent 1. FIG. 3E is a perspective view depicting a simpleexample of a hollow embolic agent 1. It is round in cross-section, has ahollow lumen 7, and a thin wall 2. It has a proximal end 18, middle 20section, and a distal end 19. As described for other embolic agentsherein, the distal end 19 is passed into the target tissues first. Thepurposes of this embolic agent 1 are the same as described elsewhereherein, but its function may be different. The thin wall 2 and hollowlumen 7, combined with the use of a flexible substance of composition,will enable this agent to fold and kink and nest very well inside thetarget tissue, as seen in FIG. 3H where a small segment of a hollowembolic agent 1 is easily kinked and folded by minimal external forces.Such kinking could occur at innumerable points along the length of theembolic agent 1. Another quality of the hollow embolic agent 1 is thatit will occupy a greater volume of space using less material compared toan otherwise similar solid filament or wire. Its lumen 7 will havepotential for flow of fluid, or creation of hydraulic pressure, or becapable of permitting insertion of a guide wire, as described here andin the detailed description of the embolic delivery system. It may alsopermit novel detachment or fragmentation mechanisms as describedelsewhere herein, notably in the detailed description of detachmentmechanisms. As will be described in more detail in the description oftraction elements 270 hereafter, traction elements 270 may be appliedinside or outside of the hollow embolic agent 1 with structure andfunction described therein.

FIG. 3F depicts is an upper perspective exploded view showing a hollowembolic agent 1, containing a lumen 7, a wall 2, a proximal end 18, amiddle section 20, and a distal end 19 similar to seen in FIG. 3E.However, there is the addition of baffles 11, which are fluid-tightplates or membranes that seal off parts of the lumen 7 from other parts.The baffles 11 connect to the wall 2 circumferentially with afluid-tight seal. A baffle 11 is shown on the distal end 19, which isshown in FIG. 3G, where it provides a seal of the distal end 19.Referring back to FIG. 3F, fluid flowing into the lumen 7 on an end ofthe embolic agent 1 would meet an obstruction upon reaching a baffle 11,and could lead to an increase in hydraulic pressure or propulsion ofembolic agent 1 forward, depending on whether it was allowed to move byexternal forces. Variations of the hollow embolic agents 1 could includevarious compositions, wall thickness, lumen sizes, and lengths. Thebaffles could have different configurations and still be in keeping withtheir intended function in this invention of creating fluid-tight sealsin the lumen 7. The baffles 11 could be of any number and spacing alongthe embolic agent 1. In other variations, the baffles could be non-fluidtight. Instead, they might contain holes or porosity or configurationsthat provide partial obstruction to flow of fluids, but not completeobstruction. In this manner drag could be produced without completeblockage of flow. The hollow embolic agent 1 may be open on both ends,closed on both ends, or open and closed on alternate ends. When closedon both ends, it may have porous seals or fluid-tight seals, which wouldor would not permit inflow of fluid into the lumen 7, respectively. Thehollow embolic agent 1 may be radio-opaque, or radio lucent, or mayutilize markers as described for other embolic agents herein.

FIG. 3I depicts a hollow embolic agent 1 containing a wall 2 and lumen 7with a baffle 11 closing the distal end 19. It would have a differentpropulsion characteristic inside an introducer catheter compared to asolid embolic agent 1 or a hollow embolic agent 1 with a baffle 11 onits proximal end 18. The hydraulic pressure would be directed moretowards the distal end 19, thus the embolic agent 1 could be less proneto buckling inside the introducer catheter 200 or embolic deliverysystem 324. In effect, it would behave somewhat as if it was pulledthrough the introducer catheter than as if it was pushed from itsproximal end 18. Much like a windsock, it would be kept fully expandedduring this phase of deployment. Once in position in the target tissues,the loss of internal pressure could result in easy kinking and foldingas desired.

FIG. 3J introduces two more contemplated embodiments that may be usedalone or in combination with other embolic agents 1 as depictedelsewhere herein. The embolic agent 1 example in this figure is hollowhaving a lumen 7 and a wall 2, round in cross section, semi-rigid, andcomposed of polymer. It also has ridges 15 along its outer wall. Theseridges may be cut or formed into the wall 2 of the embolic agent 1,having many different possible shapes depending on ease of manufacture,but here depicted as small triangular protuberances that arecircumferential around the embolic agent 1. These provide extra tractionwith an embolic delivery system 324, as in this example where feederrollers 325 are being used to drive the embolic agent 1. The feederrollers 325 also have small corresponding ridges which will be calledroller grooves 326, to provide extra traction, although in variation theroller grooves 326 may be absent. In other contemplated embodiments, anyother type of embolic delivery system 324 described in this inventionherein may be used alternatively, and the ridges 15 may still serve toprovide extra traction or desirable handling characteristics whenmanipulated by the operator's hands. Other variations also includeelements other than ridges as depicted to provide this extra traction.All of the surface characteristics depicted elsewhere herein in thedetailed description of traction elements 270 could alternatively beused. Another embodiment is the ridges 15 may not be circumferentialaround embolic agent 1. Ease of manufacture might lead to use of scoringor ridges that extend only partially around the circumference of theembolic agent 1, or that extend circumferentially with interruptions.Also shown in FIG. 3J is a longitudinal slit 17 along the long axis ofthe embolic agent 1. This is a cut through the entire wall 2 thicknesson one side (not involving the diametrically opposite wall), whichpermits the semi-rigid embolic agent 1 to be opened up along thelongitudinal slit 17 to expose the inner lumen 7, which is now not acontinuous circle. In this figure, the longitudinal slit 17 does notextend entire length of the embolic agent 1, but is incomplete at itsdistal end 19. In different embodiments, it may involve the entirelength or a lesser length than shown. The longitudinal slit 17 permitsopening of the embolic agent 1, which may then be fed onto a guide wireor other similar object using methods as described in the more detaileddescriptions of embolic delivery systems herein.

FIGS. 4A-C depict various embodiments of embolic agent 1 with screw-likethreads 16 to facilitate delivery. FIG. 4A is a surface view of a solidembolic agent 1 which is composed of metal or non-metallic materialsdescribed herein and has threads 16 circumferentially around its surfacemuch like the threads of a screw in appearance and function. Embolicagent 1 is circular in cross-section as seen in FIG. 4A-1. It isflexible as a result of its flexible composition, or if metallic, due toits very small diameter, similar to a wire strand. This embolic agent 1may be driven by a rotating threaded driver which functions like a nuton a screw, which when rotated and not allowed to move longitudinally,will drive the embolic agent 1 forward or backward, depending ondirection of rotation of driver. Alternatively, threads 16 may engagethe ridges 15 or threads 16 on feeder rollers 325 as seen in FIG. 3J.The embolic agent 1 may have a shape memory as described elsewhereherein, although shown here in its straight form as it would be whenconstrained. FIG. 4B shows a similar threaded embolic agent 1 as seen inFIG. 4A, with the addition of notches 9 at intervals along its length.It is solid and circular in cross section as seen in FIG. 4B-1. Notches9 may facilitate folding or kinking of the embolic agent 1 oncedeposited in the target tissues, and are more likely to be added forembolic agents 1 with relatively larger diameters in their main segments38. FIG. 4C shows another variation where the embolic agent 1 is notsolid. As seen in FIG. 4C-1, but is instead small wire that is wound ina manner to create an outer surface similar to the threads 16 of FIGS.4A-B. This may provide much flexibility while still permitting themechanical functions of the threads. Optionally, there may be severalweld points 21 along its length (see FIG. 4C) where adjacent coils ofthe wire are welded together. These change the characteristics of theembolic agent 1 by reducing its lateral flexibility, and decreasing itstendency to unravel when the ends are pulled in opposite directions. Thefrequency of weld points 21 serves to adjust the flexibility to desiredcharacteristics. In other variation, longitudinal stretch resistance isinstead provided by a small straight wire or fiber thread in the corethat is tethered at both proximal and distal ends of the embolic agent1, as seen in FIG. 9D.

FIGS. 5A-F are surface and cross-sectional depictions of flexible,predominantly non-metallic embolic agents 1 with radio-opaque markers 13(FIGS. 5A-E) or radio-opaque substance 14 (FIG. 5F) that will improvevisualization during fluoroscopic guidance and diagnostic imaging.Markers 13 made of dense radio-opaque metal, such as platinum, gold,tantalum, bismuth, barium, stainless steel, nickel-titanium alloy, orothers are integrated with the embolic agent 1, and as shown in FIG. 5F,radio-opaque substance 14 is diffusely impregnated in the embolic agent1 during manufacture as is sometimes utilized with angiographic orvenous access catheters in common practice. Also, elements withfunctions related to electrolytic detachment, or fragmentation of theembolic agent 1 into at least 2 fragments through use of electrolyticcorrosion, are outlined in some of the figures. The elements coating 31and capsule 43 are discussed, both describing an electrically insulatinglayer of non-metallic material surrounding a substantial portion of anelectrolytically corrodible wire to provide electrical insulation andprevent corrosion of the wire portion that it covers. In general, theterm coating 31 is used for a thin layer, and capsule 43 for a bulkierlayer, however these distinctions are relative and their characteristicscan be so similar in some embodiments that they may be nearlyinterchangeable in meaning. The need to distinguish them arises mostlywhen both layers are present in the same embolic agent 1, where thecapsule 43 is usually surrounding the coating 31.

In FIG. 5A, a long metallic wire 6 is surrounded mostly, except on itsproximal end 18, by a capsule 43, which is flexible, non-metallic,solid, and may be substantially dielectric. The wire 6 may beelectrolytically corrodible in variations where this function isdesired. It may also serve as a marker 13. In this figure, it iscentrally located in the core of the embolic agent 1 as seen in FIG.5A-1. Other variations could include a plurality of wires 6, ordifferent lengths or extent on the embolic agent 1, or located elsewherethan centrally, either within the perimeter of the cross section of theembolic agent 1, or on its outside surface. A method of manufacturecould include co-extrusion of marker(s) 13 with embolic agent 1. Inaddition to serving as a marker 13 or instead of serving as a marker 13,the wire 6 may be used to impart the desired balance of flexibility andcolumnar strength. The wire 6 may also be used to facilitateelectrolytic detachment as described herein using novel tools andmethods to expose a portion or portions of the wire 6 to make themsusceptible to electrolytic corrosion. In various embodiments, the wire6 in the proximal end 18 of the embolic agent 1 may be surrounded by thecapsule 43 as is the rest of the wire 6. In FIG. 5B, the wire 6 or wiremarker 13 is eccentric (i.e. it extends most or all of the body 40 ofthe embolic agent 1), however is not located at the center on thecross-section views of FIGS. 5B-1 and 5B-2. Two types of embolic agents1 are depicted which have two different methods of manufacture. FIG.5B-1 shows a monofilament containing the wire 6 or wire marker 13, suchas might occur if the monofilament were extruded over the wire as acapsule 43. FIG. 5B-2 shows the wire marker 13 or wire 6 is sandwichedbetween a core 12 and an outer layer 32 of the capsule 43, such as mightoccur with a co-extrusion of the 2 layers with the wire 6 in between. Asin FIG. 5A, this wire 6 may also be used to provide the desired physicaland/or electrolytic properties described herein. The wire 6 iscompletely encapsulated in this depiction, but in variation variousareas may be exposed as described herein.

In FIG. 5C, the markers 13 are small spherical shaped beads spaced apartat various intervals along the body 40 of the embolic agent 1 which is anon-metallic monofilament 5. FIG. 5C-1 shows that markers 13 arecentrally located in the cross-section of embolic agent 1, however invarious embodiments they may be positioned at various locations withinor on the surface of embolic agent 1. In FIGS. 5D and 5D-1, markers 13are bands around the perimeter of the embolic agent 1, which are swagedonto the body 40 keeping the outer diameter substantially identical tonon-banded portions of the embolic agent 1. Alternatively, these bandmarkers 13 could be sandwiched between layers 32 of the embolic agent 1(not shown). In FIG. 5E, an embolic agent 1 that is hollow (as in FIG.3E), with markers 13 which may be in the lumen 7 held in place withadhesive or by deformation of the inner wall 2 as in FIG. 5E-1 or withmarkers 13 located eccentrically in the wall 2 as in FIG. 5E-2 where itis imbedded in the substance of the wall 2 using manufacturing methodsdescribed herein or conventionally available. FIG. 5E-3 depicts aportion devoid of markers 13. Other embodiments could include variousshapes and sizes of marker 13. In FIG. 5F and FIG. 5F-1, there isdiffuse impregnation of a radio-opaque substance 14 within thecomposition of the body 40 of the embolic agent 1. FIG. 5G is a frontalview and FIG. 5G-1 is a magnified cross section view of a hollow embolicagent 1 with a lumen 7 and a wall 2, and two different types of markers13. The upper marker 13 is swaged onto the body 40 over a mandrel(inside the lumen to prevent collapse) similarly to FIG. 5D, and thelower marker 13 is sandwiched between layers 32 in the wall 2. Thisembolic agent 1 also has a fine, loosely wound helical wire 33 withinits wall 2 to prevent crushing of the embolic agent 1 upon handling orfeeding into a catheter, while still allowing flexibility and folding orbuckling. FIG. 5H is a perspective view and FIG. 5H-1 is a magnifiedcross section view of a hollow, tubular-shaped embolic agent 1 with awall 2 and a lumen 7. There is a metallic wire 6, which may beelectrolytically corrodible, running throughout most or all of the body40 within the wall 2, which is encapsulated and not exposed to theenvironment or lumen 7, similar to other variations shown or describedin FIGS. 5A-B, 5J-M, 6A, 6C-E, and 6G-K, but not limited to thesevariations. In the embodiment of any encapsulated wire variations justnamed or described elsewhere herein, encapsulation may be incomplete asexposed wire may be present to allow application of electrical currentas described herein. Wire 6 may also serve as a marker 13. It mayprovide the desired physical characteristics and/or electrolytic effectsdescribed herein. Embolic agent 1 may also utilize a coiled wire, orother wire configuration separate from wire 6, within its wall 2 forradial support, as described in FIG. 5G.

FIG. 5I is a frontal view and FIG. 5I-1 is a magnified cross sectionalview of an embolic agent 1 composed of non-metallic flexible capsule 43,which may be dielectric, substantially encapsulating several wires 6running longitudinally, oriented end-to-end, differing from FIG. 5A inthat the wires are not one continuous wire, but are separated by gaps41. This may serve purposes of creating the desired physicalcharacteristics such as more flexibility in the gaps 41, possibly alsoaided by the placement of notches 9 as in FIG. 2I, as well aselectrolytic properties serving to direct corrosion and detachment to alocation proximal to a gap. Electrical current will not pass from onewire 6 segment to the others even if within ionic solution, so ifelectrolytic detachment is performed in the manner described herein, itwill only occur along the wire 6 segment that is included in thecircuit, which may occur at any location where the manufacturer or theoperator exposes the wire 6 to the electrolytic environment such asblood or ionic fluids. The segments of wire 6 distal to the gap will notbe electrified, hastening the speed of electrolytic corrosion to thedesired point of exposure. The distance between gaps 41 in the wire 6will usually be greater than the length of the introducer catheter (notshown) so that detachment can occur at or beyond the catheter tip whilecurrent is applied to the proximal embolic agent 1 outside the body ofthe patient in the manner described herein, to a portion where the wire6 is exposed. This use of gaps 41 in the wire 6 may be applied to othervariations containing a long wire insulated by a non-metallic coating orcapsule, for example in FIGS. 5A-B and 5G-H.

FIG. 5J is a frontal view and FIG. 5J-1 is a magnified cross sectiondepicting an embolic agent 1 which includes an encapsulated wire 33where wire 33 is helically wound within the capsule 43. As in othervariations depicted herein, the body 40 is substantially dielectric andhence insulates the wire. As in other examples described herein, themetallic wire 33 may also serve as a marker 13. The use of the helicallywound wire 33 may serve to provide the desired physical handlingcharacteristics, as well as possibly serve for electrolytic detachmentas described herein. FIGS. 5K-M are each frontal views and FIGS.5K-1-5M-1 are cross section views depicting solid embolic agents 1 thatcontain a wire 6 or helical wire 33 encapsulated in the body 40 ofcapsule 43 which is non-metallic and substantially dielectric. FIG. 5Kand cross sections FIGS. 5K-1 and 5K-2 depict notches 9 in the body 40.FIG. 5L and cross sections FIGS. 5L-1 and 5L-2 depict notches 9 whichare undulating and smooth as shown. FIG. 5M and cross section FIG. 5M-1depict an encapsulated helical wire 33, which differs from FIG. 5J inthat the diameter of the helical wire 33 is closer to the diameter ofthe capsule 43, imparting different handling characteristics. In each ofthese depictions, the wire 33 may also serve as a marker 13. Variouscontemplated embodiments may include combinations of the featuresdescribed herein including notches 9 for FIG. 5M, gaps 41 in the wires,or other variations as described herein.

FIGS. 6A-6F are longitudinal frontal views and FIGS. 6A-1-FIG. 6B-1 arecross-section views for FIGS. 6A-B, of different embolic agents 1 thatare made of flexible, electrically corrodible wire 6 (e.g. stainlesssteel) or helically wound wire 33, with a thin coating 31 ofsubstantially dielectric flexible material (e.g. PTFE) or anotherpolymer of necessary thickness and lack of small holes that providessubstantial low-voltage electrical insulation. Coating 31 may notprovide substantial bulk to the overall volume of the embolic agent 1,but it may affect the handling characteristics of the wire such aslateral flexibility, and may also serve to provide lubricity or reducedcoefficient of friction as may be desired for the invention. The coating33 and its use with regard to electrolytic corrosion and detachment arevery different from conventional surface coatings of helical wires whichare intended mainly to alter handling characteristics and not forelectrical insulation. The presence of very small holes, thin areas, andflaky disruption did not completely prevent electrolytic corrosion atundesired locations as demonstrated in our tests, resulting in slowercorrosion at desired locations and undesired physical changes in thedeployed embolic agent 1. In FIGS. 6A-F, as in other embodiments ofelectrolytic embolic agents in this invention, the entire portion ofwire composed of corrodible metal that may be in the proximity of theionic medium promoting electrolytic corrosion is coated and thereforeresistant to corrosion except in any described areas where coating isremoved or intentionally not applied in order to serve as a contact forelectrification or as a site for intentional corrosion and detachment.FIG. 6A and cross section FIG. 6A-1 depicts an embodiment with completeor nearly complete coating 31 over the entire body 40 of the wire 6.Exposed wire 6 without coating 31 may be present on the proximal end(not shown) to provide contact with electrical source as describedherein. Electrolytic corrosion and detachment could only occur where asecond portion of coating is removed by operator to expose the wire 6 asdescribed herein. FIGS. 6B and 6B-1 is a variation of FIG. 6A whichincludes two or more bare portions 39 of wire 6 that are not covered bycoating 31, and are thereby available for electrical conductivity withanother wire or electrolytic fluid as described herein. The bareportions 39 may also serve as detachment points 28 where electrolyticcorrosion of the wire 6 may occur, permitting separation of the embolicagent 1 into two fragments at that location as described herein. Thebare portions 39 may occur at various locations along the body 40 of thewire 6, including areas that have been deposited within the aneurysm orcavity. FIG. 6C-F relate to variations that include helically wound wire33 with different configurations of coatings 31, each of which may havedifferent ease of manufacture, and different physical properties such ascolumn strength and lateral flexibility. However, all serve to providean electrical insulation from an ionic environment in which they mightbe positioned, such as during deployment in the tissues, whereby pointsof contact and detachment may be controlled by the placement of bareareas 39 where desired. In FIG. 6C, the insulating coating 31 is appliedto the helical wire 33 after it has been wound, with application of acontinuous layer to the internal surface 54 facing the space inside 34,and to the external surface 42. This may decrease flexibility of theembolic agent 1 due to a binding effect of the wire coils to each other,and for this reason a very pliable and stretchable coating 31 materialmight be most suitable. In FIG. 6D, the coating 31 surrounds the entiresurface of the wire 33 strand that was wound into the helix. One methodof manufacture could involve coating the wire 33 strand prior to windingthe helix, while another method could involve winding, followed bypartial stretching to slightly separate loops, followed by coating,followed by resumption of more compact depicted configuration by memoryeffect of the wire or by reshaping methods. This helical wire 33 mayretain a great flexibility since the individual coils are not boundtogether, permitting use of a coating 31 with minimal pliability ascould be advantageous for other reasons of manufacture orbiocompatibility. In FIG. 6E, the coating 31 surrounds the externalsurface 42 and distal end 19 of the helical wire 31 but not the internalsurface 54 facing the void 34 inside. This may be relatively simple tomanufacture, however may have similar implications for lateralflexibility as described for FIG. 6C and may benefit from a pliable andstretchable coating 31 material. FIG. 6F depicts a variation of helicalwire 33 with coating 31 most notable for its presence of non-coated bareportions 39, which may serve as detachment points 28, at variouspossible locations along the body 40 of the helical wire 33, similar tothat depicted for the non-helical wire in FIG. 6B. These bare areas maybe placed by the manufacturer or the operator using tools as describedherein, and may occur in all embodiments of helical wires 33 in FIGS.6C-F. Various embodiments may include all coating 31 types depicted inFIGS. 6C-E. FIG. 6F also depicts the presence of radio-opaque markers13, showing how they may be positioned internally within the void 34 inthe interior of helical wire 33, as may occur with any type of helicalwire in this invention. In a common embodiment the markers 13 would beslightly proximal to the bare portions 39 so that the proximal end ofthe embolic agent 1 is easily identified after detachment occurs at thedetachment point 28. As in other helical embolic agents in thisinvention, those in FIGS. 6C-6F may contain a longitudinal straight wireor fiber which is tethered at the ends or two or more other points alongthe embolic agent 1 within its core to impart handling characteristicsor resist stretching or unraveling.

FIGS. 6G-I are frontal views and FIGS. 6G-1, 6H-1, and 6I-2 are crosssection views of embolic agents 1 with complex coatings andencapsulations which may be used for electrolytic detachment asdescribed in the simpler embodiments above. In FIG. 6G, anelectrolytically corrodible wire 6 has a thin coating 31 of dielectricflexible material as described in FIG. 6A, and this coated wire 6 issurrounded by a helical winding of a flexible, non-metallic monofilament5. This may provide desired bulk and thrombogenicity and desiredradio-density properties (such as to prevent excessive accumulation ofradio-dense metal in the aneurysm or cavity by occupying space withnon-radio-dense material). The helical winding of the filament 5 mayfacilitate lateral flexibility of the embolic agent 1 compared to abulky solid encapsulation. The inner coating 31 provides electricalinsulation even though the wound monofilament 5 may be porous to liquidand therefore not completely insulating. The wound monofilament 5 may beprevented from unraveling or separating from wire 6 by use of adhesiveor heat treatment to create enough bonding between the coils, withoutinducing excessive overall stiffness of the embolic agent 1. Invariation, the mono-filament 5 could be substituted with a singlemulti-stranded filament 4 that is braided, yarn, bundled, or woven forslightly different handling properties. FIG. 6H also includes anelectrolytically corrodible wire 6 with a thin dielectric coating 31.However, it is surrounded by multiple small diameter monofilaments 5which are bundled and helically wound around the wire 6. This mayprovide desired bulk, thrombogenicity, radio-opacity characteristics,and flexibility, with preservation of electrical insulation by thecoating 31 where desired. In variation, each monofilament 5 may besubstituted with non-metallic multi-stranded filament 4. The filamentsin FIGS. 6G-H may be amenable to heat melting such that a bare portionof the wire could be created using a hot wire or readily availablecautery pen or other source of heat to cut and melt the strands withoutfraying at the modified area.

FIGS. 6I, 6I-1, and 6I-2 depict an embolic agent 1 which includes anelectrolytically corrodible wire 6 with a dielectric coating 31, whichis mostly encapsulated in a capsule 43 of relatively bulky, flexible,non-metallic solid material roughly similar to FIGS. 5K-M, howeverdifferent in that in FIG. 6I the notches 9 in body 40 are deep enough tocompletely expose the coating 31 on the wire 6. The notches 9 help toprovide lateral flexibility, as well as facilitating complete exposureof the wire 6 by the operator, by removing a short segment of coating 31where exposed in the notch 9 through means described herein, andresulting in creation of a potential electrolytic detachment point 28 ofthe operator's choosing. In variation, the wire 6 may be completelyexposed in the notch 9, (i.e., the coating 31 may be absent in a smallbare area in the notch 9), preventing need for the operator to removethe coating 31 in this location to expose the wire 6, howeverpotentially resulting in multiple sites of potential electrolyticcorrosion or detachment. Variations in FIGS. 6G-I may include use ofhelical wire instead of straight wire, application of radio-opaquemarkers, exposure of the wire on the proximal end of the embolic agentwhich will not be deployed within the aneurysm or cavity, gaps in thewire, and other variations as described herein.

FIG. 6J includes sequential views of a variation of embolic agent 1 withencapsulation of an electrolytically corrodible wire 6, which also haseasily removable seals 48 that provide electrical insulation of the wire6 while allowing the operator to expose the wire 6 in the desiredlocation(s) to permit electrolytic detachment in keeping with theobjectives of this invention. On the left is a longitudinal section withcross section views depicted in FIGS. 6J-1, 6J-2, 6J-3 and 6J-4. Arrowindicates transformation by operator to configuration on right, where alongitudinal section is depicted and includes cross section views FIGS.6J-5, 6J-6, 6J-7 and 6J-8. Referring to the figure on left, the embolicagent 1 has a capsule 43 that surrounds a majority of the wire 6,providing electrical insulation. It has no inner coating. There are gaps41 in the capsule 43, which are a type of notch 9 where adjacentsegments of capsule 43 are completely separate from each other. Easilyremovable seals 48 are dielectric, used to insulate the wire 6 at thegaps 41 by providing a fluid-tight seal with the adjacent segments ofcapsule 43, effectively maintaining insulation of the wire 6. The easilyremovable seals 48 are very flexible, allowing bending of the embolicagent 1 at the notches 9 where the capsule 43 provides less restrictionto motion than elsewhere in the body 40. The easily removable seals 48may be easily removed by the operator when desired, exposing theunderlying wire 6 at the bare portion 39, making it susceptible toelectrolysis at the potential electrolytic detachment point 28 Threedifferent types of easily removable seals 48 are depicted in thisfigure, although actual device may only incorporate one type in one ormore locations. The gap 41 depicted on top is sealed with the easilyremovable seal 48 called tape 45. The tape 45 is a thin strip offlexible, fluid-tight, non-metallic dielectric material with adhesive onone surface that can be applied to the embolic agent 1 at manufacturecircumferentially around the gap 41, adhering tightly to the adjacentsegments of capsule 43 and providing a fluid-tight seal under theconditions of use of the device. The operator may easily peel off thetape 45, exposing the bare area 39 or the wire 6, and establishing apotential electrolytic detachment point 28. The middle gap 41 depicts aneasily removable seal 48 provided by sealant 46. Sealant 46 is acompound which may be applied at manufacture in liquid or semi-solidform, and curing to a pliable, flexible solid or semi-solid thatsurrounds the wire 6 and conforms to the edges of the capsule 43. Theoperator may easily peel or rub this sealant 46 off when desired. Invariation, the sealant 46 may be dissolved by a solvent that is appliedto it. Choice of compositions of sealant 46, solvent, and capsule 43will intentionally permit dissolution of sealant 46 but not of capsule43 or wire 6, so that capsule 43 remains intact, but wire 6 bare area 39is exposed, creating potential electrolytic detachment point 28. Anexample of a possible solvent is Dimethyl Sulfoxide (DMSO). Othervariant sealants 46 have a melting point higher than the capsule 43 butmuch lower than wire 6. Application of heat slightly greater thanmelting point of sealant 46 using tools described herein will result inliquefaction of sealant 46, exposing bare area 39. The bottom gap 41depicts an easily removable seal 48 comprised of a sealant plug 47,which is firm but flexible, pliable, and solid or semi-solid. It isroughly shaped like a disk but with upper and lower surfaces which matewith the adjacent segments of capsule 43 to provide a seal, and closelysurrounds the wire 6, with intention to provide watertight electricalinsulation of the underlying wire 6. The sealant plug 47 also has aradial slit 44 as seen if FIG. 6J-4, which due to the plug's 47 pliablenature, may be widened to permit application of the plug 47 to theembolic agent 1 as shown on the left, as well as easy removal by theoperator, creating the bare area 39 and potential electrolyticdetachment point 28 as seen on the right.

FIG. 6K includes sequential dimensional frontal views and FIGS. 6K-1 and6K-2 include cross section views teaching the concept of electrolyticdetachment in a very simple form. On the left, the embolic agent 1 isshown intact, with an electrolytically corrodible wire 6 encapsulatedwithin a capsule 43, except for its proximal end 18 where the wire 6 isexposed to serve as an electrical contact 36. This exposure may beduring manufacture, or may be created by the operator using methodsdescribed herein, and may involve proximal areas other than the mostproximal end of the embolic agent 1 depicted. After near completeadvancement of the embolic agent 1 into the target tissues 589, a smallfocal portion of the capsule 43 is removed using a tool or any of thevarious methods described herein, said removal occurring at themid-portion 20 of the embolic agent 1 which is still outside the body inthe operating field, creating the depiction in the middle 20, where thebare portion 39 of the wire 6 is now seen, constituting a potentialdetachment point 28, as seen in the middle drawing. The embolic agent 1is advanced further through the introducer catheter (not shown), placingthe distal end 19 and bare portion 39 into or near the target tissues589 in the body where desired as seen in the third drawing on the right.Electrical energy is applied. The electrical source 176 outside of thebody is connected to electrical wires 220, one connected to the barearea 39 at the proximal end 18 of the embolic agent 1 which is outsideof the body and not in electrical continuity or contact with the body orbody fluid in the target tissues 589, and the other in contact with thebody or more directly to the ionic body fluid, such as blood, in thetarget tissues 589 bathing the mid portion 20 and distal portion 19 ofthe embolic agent 1, including the bare portion 39 of the wire 6 at thedetachment point 28 as discussed elsewhere herein. As shown,electrolytic corrosion occurs at the detachment point 28, and the distalportion 19 of the embolic agent 1 is now physically separated from theremainder, which may then be withdrawn from the body from the operator,leaving only the distal portion 19 within the body at the precisedesired location. Many different types of embolic agents andconfigurations, different mechanisms of energy application, and otherspecific novel devices to facilitate and improve this process aredescribed in this invention and this simple example serves to introducethe concept in a simple form.

FIG. 6L is a schematic representation to teach a concept that may bementioned in this invention relating to distances between potentialdetachment sites 28 of an embolic agent 1, especially when such sitesare placed by the manufacturer instead of the operator. As shown, L isthe length of the introducer catheter 200 from proximal end 206 todistal end 210 which may be any length but will generally be between 10cm and 110 cm. In general, the distance between potential detachmentsites 28 of the embolic agent 1 will be at least greater than L, so thatwhen it is passed through the introducer catheter 200, the distaldetachment site 28 may be beyond and outside the distal end 210 of theintroducer catheter 200 while the proximal detachment site 28 is outsideof the proximal end 206 of the introducer catheter 200 where it isaccessible to the operator outside of the patient's body. Although thisdescription may help to understand a typical embodiment of the inventiondisclosed herein, exceptions occur and are described herein, and othervariations may occur in keeping with the spirit of the invention.

FIG. 6M is a frontal view of an embolic agent 1 composed of a conductivecorrodible helical wire 33 with a coating 31 over most of its surface asdescribed herein (FIGS. 6C-E) where at least one potential detachmentarea 28 is produced at the time of manufacture or by the operator bystretching or shaping the coiled wire 33 in a controlled manner tostraighten the wire while separating the coiled segments from eachother, and stripping the coating from the small area, as shown. Thisstraight segment has no coating 31, resulting in a bare portion 39, andtherefore susceptible to electrolytic corrosion using principles andmethods described in this invention. In keeping with descriptions inthis invention, the bare portion(s) 39 may be created by themanufacturer or the operator to direct detachment 28 of the embolicagent 1 as desired. In variation, the helical wire 33 may have a shortbare portion 39 without having a straight portion, (i.e., there may notnecessarily be any alteration of the helical wire's 33 shape associatedwith the presence of the bare portion 39).

FIGS. 6N-O are longitudinal sections of two types of embolic agents 1using electrolytically corrodible connectors 35. FIG. 6N includes two ormore segments of electrically conductive, non-electrolyticallycorrodible helically wound wire 33 (e.g. platinum) with one or morepotential detachment points 28 at the site of several connectors 35. Theconnectors 35 are straight, substantially cylindrical, pin-like soldmetallic structures made of conductive, electrolytically corrodiblematerial which are non-detachably attached to the internal surface ofthe helical wire 33, partially occupying the space inside 34, leaving abare portion 39 between the segments 52 of helical wire 33. They areattached by mechanical, frictional, welding, or chemical bond.Electrolytic corrosion may be directed to the detachment points 28because electrical current may be conducted to them through theconductive, non-electrolytically corrodible helical wire 33 segmentsfrom a source remote from the detachment point 28. Notches 9 may beoptionally present, consisting of narrowing of the connectors 35 at theintended detachment points 28, to facilitate and direct corrosion of thethinner portions. The notches 9 may be from machining, stretching, orpre-corrosion of the connectors 35 at manufacture. FIG. 6O is similar toFIG. 6N but has further addition of a non-conductive insulated coating31 to the helical wire 33 in possible manners shown in FIGS. 6C-E whichdoes not cover the detachment points 28 on the center of the connectors35, thus directing corrosion to detachment points 28. This may permitthe use electrolytically corrodible metals such as stainless steel forthe helical wire 33 since corrosion will not occur due to insulation.The points of contact between connectors 35 and helical wire 33 willhowever not be coated so that electricity may be conducted along theembolic agent 1 from segment 52 to segment 52. In variation of FIGS.6N-O, variations of tape, sealants, or plugs as described in FIG. 6J maybe easily adapted for similar function, to provide easily removableseals which could insulate the connectors 35 from electrolytic corrosionuntil precise choice of detachment point 28 is chosen by operator fordetachment. As with all embolic agents in this invention, radio-opaquemarkers 13 may be added as described.

FIGS. 6P-T depict novel embolic agents 1 that permit variable,operator-determined length of detached embolized segment(s) 52 utilizingelectrolytic detachment without the need for modification of the embolicagent 1 by operator prior to detachment. FIGS. 6P-T all depict embolicagents 1 that have a repeating cycle of a segment 52 of non-conductingmaterial such as non-metallic monofilament 5 or coated wire, then anelectrical contact 36 which conducts electricity to a bare portion 39 ofcorrodible connector 35 which is a potential detachment site 28, toanother segment 52 of non-conducting material such as monofilament 5,and then repeat. Such embolic agents 1 may function in combination withintroducer catheters that have electrical contacts near their distalends, to conduct electricity to the contacts 36 on the embolic agent 1,as described later in this invention, for example in FIGS. 12F, 12G,12H, and 14B. FIG. 6P is a frontal view from a slightly elevatedperspective and FIGS. 6P-1, 6P-2 and 6P-3 are three cross sectionalviews depicting an embolic agent 1 whose main body 40 is composed mainlyof a non-conductive material in the shape of a monofilament 5 asdescribed herein. Rigidly attached is at least one area of asubstantially noble or non electrolytically corrodible conductivematerial such as platinum that provides an electrical contact 36 that isroughly disc shaped and is seen in FIG. 6P-1 to have a hollow centerthrough which a metallic corrodible and conductive connector 35 may passand to which said contact 36 is connected. During manufacture, thiscontact 36 may be swaged onto the monofilament 5 and connector 35simultaneously while they are held end-to-end as shown, and/or could beattached using adhesive, bonding the segments 52 of monofilament 5 intoa long embolic agent 1 with adequate tensile strength. The contact mayalso serve as a marker 13 especially since minimally corrodible metalssuch as platinum serve well as markers 13. The upper portion of theconnector 35 is shown non-detachably attached to the distal end 19 ofthe next segment 52 using a different method; the connector 35 isinserted into a hollowed space in the monofilament 5, and a marker 13 isswaged around the monofilament 5, providing a strong connection betweenconnector 35 and monofilament 5. Adhesive could also be used. Thesegments 52 of monofilament 5 are therefore connected into a continuousembolic agent 1 with adequate tensile strength. These 2 methods ofbonding the elements may be interchangeable, using one or the other onboth sides of the connector 35, or substituting with other conventionalmethod providing the same function. There may be a plurality of segment52 connections along the embolic agent 1. Such a novel configurationprovides for novel function, in that electrical current passing to thecontact 36 via a wire in the electrolytic introducer catheter thatcontacts it (not shown) as will be described later, will then conductinto the corrodible connector 35, and said connector 35 may thus undergoelectrolytic corrosion and detachment at detachment point 28. Thesubstantially non-corroding contact 36 serves to provide constantcontact with the mating contact of introducer catheters duringelectrolysis when corrosion is occurring in the corrodible segment 52 ofthe connector 35, and is likely to occur at the indicated detachmentpoint 28 instead of point of contact with the contact 36 since it is notin contact with the ionic fluid at the latter location. In this example,a second marker 13 is present as a band around a narrowing of themonofilament 5 as is often used conventionally. This second marker 13may be useful for determining that proper separation of the segments 52has taken place, and that the proximal end 18 has separated from thedistal end 19 so that the distal end 19 may serve as embolic agent 1 inthe tissues while the proximal end 18 may be removed from the body.Other contemplated embodiments that could provide similar novel functioninclude the use of a multi-strand non-metallic filament instead of themonofilament 5, presence of other markers or a wire inside the filamentto provide structural support, use of a non-corrodible helical wire 33or straight wire, or a coated corrodible helical wire or coated straightwire instead of the monofilament 5, so long as said wires were not inelectrical continuity with the connector(s) 35. In variation thisdetachment mechanism does not need to be in series, and may only bepresent in one location, providing novel detachment function inconjunction with a conductive electrolytic catheter described in thisinvention.

FIG. 6Q is a longitudinal section view and FIG. 6Q-1 is a cross sectionview depicting an embolic agent 1 which may function roughly similarlyto the embodiment shown in FIG. 6P but whose structure permits use offewer sub-elements with possible simplification of manufacture anddecreased cost. It has segments 52 of non-metallic monofilament 5separated by notches 9, said segments 52 acting as insulating capsules43 for segments of electrolytically corrodible wire 6 which areseparated by dielectric gaps 41 to prevent continuous conduction ofelectricity along the entire length of the embolic agent 1. In thenotches 9, the corrodible wire 6 is not coated or encapsulated as is abare portion 39 which may be a detachment point 28 with electrolysis.Although the precise position of the wire 6 within the capsule 43 is notlimiting and could vary in different embodiments, in the notches 9 thewire 6 is positioned eccentrically as shown, in order to touch the sidesof an introducer catheter through which it will be advanced. Saidintroducer catheter would have a contact point within its distal lumenas seen in some varieties described herein, which would come intoelectrical contact with the contact 36 of embolic agent 1. When providedwith the opposite polarity contact within the surrounding tissues andfluids, corrosion at the detachment point 28 will separate the desiredsegments 52 of embolic agent 1. The operator may direct the detachmentto the specific desired site by aligning the desired contact 36 with thecontact on the introducer catheter. The dielectric gaps 41 betweensegments 52 of wire 6 will prevent corrosion of any other of the manypossible bare portions 39 along the embolic agent 1.

FIG. 6R is a longitudinal section and FIG. 6R-1 is a cross section viewdepicting another embolic agent 1 which may be used similarly asdescribed for FIG. 6Q but has different structure, mainly due to theaddition of a non-corrodible wire 49 to serve as an electrical contact36. In FIG. 6R, and as shown in FIG. 6Q, the discontinuous corrodiblewire 6 is contained in a capsule 43 except the bare portions 39 whichmay serve as detachment points 28 in the notches 9, and has dielectricgaps 41 between wire segments 52. In FIG. 6R, the corrodible wire 6 doesnot serve as a contact 36, but instead electricity is conducted to thecorrodible wire 6 via a contact 36 comprised of a non-corrodible wire 49that extends both inside and outside the capsule 43 as shown. Inside thecapsule 43, the non-corrodible wire 49 is in direct contact with thecorrodible wire 6. As with FIG. 6Q, the contact 36 may contact thecontact within the introducer catheter as described herein. FIGS. 6P-Rhave different manufacturing implications but may provide roughlysimilar functionality.

FIG. 6S is a longitudinal section and FIG. 6S-1 is a cross section of anembolic agent 1 which will also have similar functionality as describedin FIGS. 6P-R, however depicts an embodiment that utilizes a helicalwire 33 throughout most of its length instead of materials described forthe other embodiments. Embolic agent 1 has segments 52 ofelectrolytically corrodible helical wire 33 which are protected fromelectrolytic corrosion by a coating 31 as shown. In variation,non-electrolytically corrodible helical wire could be used without acoating. A connector 35 composed of an electrolytically corrodible metalis non-detachably secured to adjacent segments 52 of helical wire 33which are separated by a notch 9, connecting them with adequate tensilestrength for purposes described herein. Electrical contacts 36 composedof a non-corrodible conductive metal are swaged or soldered or adherednon-detachably to the connector 35, providing a means for electricity tobe conducted from a contact in the introducer catheter (not shown) tocontact 36, then to the connector 35 which has a bare portion 39 wherecorrosion may occur and is therefore a detachment point 28. The contact36 may also serve as a marker 13. Non-conducting adhesive 50 binds andinsulates portions of the components helical wire 33, connector 35, andcontact 36 as shown, preventing conduction from the connector 35 orcontact 36 to the helical wire 33 segments 52. Alternatively, anon-conductive coating 31 may be applied to the portions the connector35 and contacts 36 that contact the helical wire 33. A plurality ofthese connections, at many possible distances apart, may be present.Current applied to a contact 36 will only energize the correspondingconnector 35 and no others since current cannot pass through the coating31 to the helical wire 33 and hence to adjacent segments 52, so precisepoint of detachment 28 can be directed by the operator by positioningrelative to the introducer catheter without previous modification of theembolic agent 1 as described herein. In variation, one of the contacts36 or markers 13 may be omitted and the remaining functions stillprovided.

FIG. 6T is a longitudinal section and FIG. 6T-1 is a cross section of avariation of FIG. 6S where a different structure to the connector 35,marker 13, bare portion 39, and detachment point 28 are present,although operator usage is roughly similar. The corrodible helical wire33 segments each contain a detachment point 28 where a bare portion 39is present as shown, involving as few as one coil or even a tiny portionof one coil, while the remainder of the helical wire 33 segment isrendered non-corrodible by coating 31. Current from a contact in anelectrolytically-adapted introducer catheter is conducted to the helicalwire 33 in the lower segment 52 at the intrinsic electrical contacts 51with the connector 35 where it touches the internal surface 54 of thehelical wire 33 adjacent to the space inside 34, where there is nocoating. Only the external surface 42 is covered and insulated bynon-conductive adhesive 50. Therefore the only electrified bare portion39 of corrodible metal is at the detachment point 28 shown so is theonly area where corrosion will occur. The proximal portion of the uppersegment 52 of helical wire 33 has circumferential coating 31 and willnot be energized when the electrical current is activated and directedby the operator to the depicted contact 36. A plurality of theseconnections 35 will permit choice of location for detachment withoutoperator modification of the embolic agent 1 by positioning of selectedcontact 36 with the corresponding contact in the introducer catheter.

FIGS. 6U-6Y-1 are longitudinal section and cross section views depictingnovel embolic agents 1 that permit variable, operator-determined lengthof detached embolized segment(s) 52 utilizing electrolytic detachment 28after extracorporeal modification of the embolic agent 1 by operator todirect detachment 28 to the desired site. The embolic agent 1 becomesone electrode, and the opposite electrode is supplied by contact at theskin or on a novel electrolytic catheter as part of this invention.Operator modification of embolic agent 1 is not at detachment point 28and remains extracorporeal for FIGS. 6U-W, and is at detachment point 28for FIGS. 6W-Y. FIGS. 6U, 6U-1 and 6U-2 depicts an embolic agent 1 whichincludes a plurality of repeating segments 52, each including a capsule43 encapsulating the majority of a segment 52 of electrolyticallycorrodible wire 6, said wire 6 bridging adjacent capsules 43, therebyserving as a connector 35, which has at least one bare portion 39 or isentirely bare, thereby serving as an electrolytic detachment point 28 inthe notch 9 between capsule segments 52. A dielectric gap 41 existsbetween adjacent wires 6 to prevent conduction from one wire 6 to thenext. To detach the embolic agent 1 at the desired location, theoperator will first use a tool extra-corporeally as described herein toremove a focal portion of capsule 43, at a location such as examplemodification site 53, to expose the wire 6 creating an electricalcontact proximal to the intended detachment site 28, and then applycurrent to the newly created bare portion (not shown) contact which willenergize the single desired intra-corporeal detachment site 28 withoutenergizing potential detachment sites 28 more distally since thedielectric gaps 41 exclude them from the electrolytic circuit. Thedistance from extracorporeal modification site 53 to nearest distaldetachment site 28 will usually be greater than the length of theintroducer catheter with this variation. Possible methods of manufacturecould include extrusion of capsule 43 over wire segments, or extrusionof capsule 43 over a long continuous wire followed by laser disruptionof wire through capsule 43 to create dielectric gaps 41. Capsule 43 maybe burned or cut away to create notches 9.

FIG. 6V with cross section FIG. 6V-1 depicts an embolic agent 1 withrepeating segments 52 of helical wire 33, which may be composed ofelectrolytically corrodible metal with a coating 31 as depicted, or witha non-corrodible metal in variation. The segments 52 are connected byconnectors 35 composed of electrolytically corrodible metal which isnon-detachably bonded to the internal surface 54 of the helical wire 33.The coating is absent for enough helical wire 33 to create an intrinsicelectrical contact 51 with the connector 35, and external surface 42 ofhelical wire 33 has coating or non-conductive adhesive 50 so that theonly exposed surface of connector 35 is the bare portion 39 betweensegments 52 of helical wire 33. The bond between the connector 35 andmore distal segment 52 of helical wire 33 includes insulating coating 31on helical wire 33 to prevent electrical contact 51 with the connector35, which may further be prevented by a coating 31 around the surface ofthe involved portion of the connector 35. Said bond may be created bynon-conductive adhesive 50 or other conventional means. The operator mayremove a portion of coating 31 from the proximal segment 52 of helicalwire 33 to apply current, which will be conducted to the bare portion 39of the connector 35 serving as the detachment point 28. Conduction maynot occur to more distal connectors 35 which will not undergoelectrolytic corrosion.

FIG. 6W with cross section view FIG. 6W-1 depicts an embolic agent 1with repeating segments 52 of helical wire 33 composed ofelectrolytically corrodible metal with a coating 31. The segments 52 areconnected by connectors 35 composed of dielectric material which isnon-detachably bonded to the internal surface 54 of the helical wire 33,in this example by non-conductive adhesive 50 although otherconventional means could be used. The coating is absent on a bareportion 39 of the helical wire 33 slightly proximal to the connector 35.The operator may remove a portion of coating from the extracorporealproximal segment 52 of helical wire 33 to apply current, which will beconducted to the bare portion 39 of the helical wire 33 serving as thedetachment point 28. Conduction may not occur to more distal segments 52which will not undergo electrolytic corrosion.

FIG. 6X and cross sections views FIGS. 6X-1 and 6X-2 depicts an embolicagent 1 with a continuous electrolytically corrodible wire 6 covered onmost of its length by a coating 31 except for a bare portion 39 whichserves as an electrical contact 36 near the proximal end 18. Segments 52of tubing 55 with a wall 2 and a hollow portion 22 surround the wire,with alternating repetition of attached versus non-attached segments 52.Approaching the distal end 19, a metallic marker 13 is swaged onto thetubing 55, thereby gripping the wire 6, creating a fixation point 29between wire and tubing 55 to prevent sliding motion between them. Inthe middle portion 20, the segment 52 of tubing 55 is not fixed to thewire 6 and may slide, constrained only by butting against adjacent fixedsegments 52. These segments 52 of tubing 55 add bulk and body to theembolic agent 1. Near the proximal end 18, attachment at fixation point29 is achieved without swaging, and instead may be bonded by adhesive,heat shrinking, heat melting, or other conventional means. Two differenttypes of fixation 29 are shown only for demonstration means and it islikely that only one type of fixation means would be employed for allfixation points 29. Current may be applied to extracorporeal contact 36,and detachment 28 will occur at one of potential detachment points 28which was stripped of coating 31 by operator as described herein.

FIG. 6Y and cross section 6Y-1 depicts an embolic agent 1 withsimilarities to that depicted FIG. 6X but utilizing segments 52 ofhelical wire 33 instead of tubing 55. The segments 52 of helical wire 33are protected from electrification and hence electrolytic corrosion by acoating 31 on the straight wire 6 and detents 56 that are roughlydisc-shaped in this depiction and, in variation may be other shapes,said detents 56 being non-detachably and non-slidably attached to thewire 6 using solder, adhesive, compression, or other conventional means.Said segments 52 surround the straight wire 6 which occupies the spaceinside 34, but said segments 52 are not attached and may slide on thewire, being detained only at the detents 56, providing flexibility tothe embolic agent 1. Corrodible wire 6 is covered on most of its lengthby a coating 31 except for a bare portion 39 which serves as anelectrical contact 36 near the proximal end 18. Current may be appliedto extracorporeal contact 36, and detachment 28 will occur at one ofpotential detachment points 28 between detents 56 which was stripped ofcoating 31 by operator as described herein (shown here beforestripping). In variation, easily removable seal 46 as described in FIG.6J may be utilized in the space between the paired detents 56 tofacilitate operator modification.

FIGS. 7A-C are each sequential frontal views depicting embolic agents 1and very simple mechanical methods of detachment using extra-corporealmodification by the operator. In FIG. 7A, an embolic agent 1 comprisedof a simple long monofilament 5 undergoes the “cut and retract” method.On the left, embolic agent 1 is seen extending throughout the introducercatheter 200 from the proximal end 206 to the target tissues (not shown)beyond the distal end 210 of the introducer catheter 200, where thedistal end 19 of the embolic agent 1 is coiled in a helix. In thisfigure, it is now being retracted by pulling on the proximal end 18, asshown by the arrow, thus removing some a portion of the embolic agent 1from the target tissues, back into the extracorporeal operating fieldproximal to the proximal end 206 of the introducer catheter 200. In themiddle figure, the embolic agent 1 is being cut by an embolic detachmenttool 160, which is a pair of scissors. In the same figure, an introducersleeve 216 with a flared end is slipped over the severed end of theembolic agent 1 as shown. The introducer sleeve 216 is then pulled downso that the severed end of the embolic agent 1 is inside it (not shown).Then, a pusher element 90 may be brought into the flared end of theintroducer sleeve 216, where its tip 94 will abut the embolic agent 1.The embolic agent 1, pusher element 90 (not shown until third drawing insequence), and introducer sleeve 216 may all now be pushed in unisonuntil the introducer sleeve 216 abuts the hub 201 of the proximal end206 of the introducer catheter 200. Then, the introducer sleeve 216 willremain stationary as the severed end of the embolic agent 1 is pushedinside the introducer catheter 200, and the introducer sleeve 216 maynow be slipped off the proximal end 91 of the pusher element 90 anddiscarded. Now, as seen on the right, the tip 94 of the pusher element90 pushes the embolic agent 1 through the introducer catheter 200 to thetarget tissues as indicated by curved arrow. The pusher element 90 isnow easily removed by retraction. This technique will leave the desiredamount of embolic agent 1 within the tissues as determined beforeretraction and severing. This permits deployment of desired amount ofembolic agent 1 while utilizing severing or detachment techniquesoutside of the body rather than close to the target tissues, asdescribed elsewhere herein, and serves as simple and economical way touse the described embolic delivery systems to administer embolic agentsthat are much longer than conventional agents.

FIG. 7B shows a method of detachment of the embolic agent 1 that permitsrepositioning of the embolic agent 1 after modification by operator, butprior to detachment, with option to detach when detachment point 28 ispositioned in the target tissues beyond the tip 211 of the introducercatheter 200. On the left, the distal end 19 of the embolic agent 1,which is a non-metallic monofilament 5 in this example, is partiallydeployed in the abnormal tissues, while the proximal end 18 is seenproximal to the introducer catheter 200, which also has proximal 206 anddistal 210 ends. In the figure on the left, it is determined that theamount of embolic agent 1 that is deployed in the tissues is the idealamount. To detach it with this extent of embolic agent 1 in the tissues,the embolic agent 1 is first retracted by pulling down on the proximalend 18 as indicated by the arrow, which results in the partialretraction of the distal end 19 as shown by the curved arrow. Once theembolic agent 1 has been retracted a distance approximately equal to thelength of the introducer catheter 200 (middle drawing), then it isscored with the scoring tool 163, which cuts a fine score around thecircumference of the embolic agent 1 but does not cut through its entirediameter. The embolic agent 1 is now weakened, but intact at thedetachment point 28. It may now be pushed by the operator into theintroducer catheter 200 as indicated by the arrow, which pushes thedistal end 19 back into the tissues as they were before retraction andscoring. Once the scored portion has exited the introducer catheter 200(drawing on right), the proximal end 18 of the embolic agent 1 isrotated by the operator or equipment controlled by the operator. Sincethe distal end 19 will not easily rotate due to extensive deployment andnesting, there will be twisting forces on the weakened score zone,resulting in complete detachment. Now, the proximal portion 18 of theembolic agent 1 may be removed and embolization is complete.Alternatively, the embolic agent 1 may not need to be retracted prior toscoring. The final length may be estimated, and the score may beapplied, then the embolic agent 1 may be pushed in and twisted off.

FIG. 7C shows a method of detachment that permits repositioning of theembolic agent 1 after extracorporeal modification, consisting ofweakening by stretching, by operator prior to detachment, with option todetach when detachment point 28 is positioned in the target tissuesbeyond the distal tip 211 of the introducer catheter 200 as seen in FIG.7B. The embolic agent 1 is a monofilament 5, which can be stretched whengrasped and pulled apart, as shown by the arrows. This results in aweakened, narrow portion as seen on right. This permits pushing andretraction of the distal portion 19 when the proximal end 18 ismanipulated by the operator. As in FIG. 7B, it is detached by twistingthe proximal portion 18 until it breaks at the detachment point 28. Thisweakening may be enhanced by scoring as seen in FIG. 7B. In variation,there are transitions at regularly spaced locations along the embolicagent 1 where the material is more susceptible to stretching andweakening. These areas may also serve as extra flexible areas fornesting.

FIG. 8A-11C depict detachment systems for embolic agents which do notrely mainly on electrolytic means and are predominantly mechanical,although may additionally include electrolytic means. FIG. 8A is alongitudinal section view (left) and a 4 part sequential perspectiveview (right) teaching basic concepts of mechanical detachment anddepicting a specific embolic agent 1 and pusher element 90 with ascrew-type detachment permitting a controlled advancement or retractionof the embolic agent 1 via the pusher element 90 under operator control.The left drawing shows a longitudinal section of the distal end 92 ofthe pusher element 90, containing traction elements 270 in form ofthreads 276, which are specially designed to interface as shown with theinner hollow space inside 34 at the proximal end 18 of the embolic agent1, which is a helically wound wire 33. In the sequential drawingsbeginning with the first drawing, a pusher element 90, introducercatheter 200, and embolic agent 1 are shown, where the dotted arrowindicates that the distal end 92 of the pusher element 90 is insertedinto the space inside 34 of the helical wire 33, which may have beensevered as described herein to the appropriate length by the operator.The distal end 92 of the pusher element 90 has traction elements 270consisting of threads 276, similar to threads on a screw or bolt, whichmate with the pattern on the internal surface 54 of the embolic agent 1.Progressing to sequence on the right, the pusher element 90 is rotatedand screwed into the embolic agent 1 which is not rotated, thusresulting in the pusher element 90 advancing into and becoming rigidlyattached to the embolic agent 1. The operator may now advance the pusherelement 90 and therefore the embolic agent 1 into the lumen 209 of theintroducer catheter 200, thereby providing a firmer attachment of pusherelement 90 to embolic agent 1 by constraining the helical wire 33 fromexpanding or spreading apart, since the internal diameter of the lumen209 is very slightly larger than the outer diameter of the embolic agent1. Now, the embolic agent 1 may be advanced or retracted by manipulationof the pusher element 90 by the operator directly or indirectly. In thisexample, the control over the embolic agent 1 persists even after theembolic agent 1 has been extruded completely past the distal end 210 ofthe introducer catheter 200 into the target tissues, and is no longerconstrained within the lumen 209 of the introducer catheter 200. Thethird sequential drawing shows the pusher element 90 being unscrewedfrom the embolic agent 1 with a counterclockwise rotation about its longaxis (depicted by arrow). The pusher element 90 may then be removed.Prevention of corresponding rotation of the embolic agent 1 which mightprevent unscrewing would usually be accomplished due to the substantialextent of the length of embolic agent 1 deployed in the target, usuallyin a bent, kinked, or curved manner, providing for some degree ofresistance to rotation of the embolic agent 1 about its long axis.Partial rotation of the embolic agent 1 could still result indissociation since the pusher element 90 could be rotated freely, sorotations could be continued until dissociation occurred. In the finaldrawing of the upper sequence, the pusher element 90 has been removed,and a different pusher element 90, in this example a conventionalhelical wire 33 is passed into the introducer catheter 200 to push theembolic agent 1 beyond the distal tip 211 of the introducer catheter 200to the target tissues, moving in the direction shown by the dashedarrow. In variation of method where the threaded pusher element 90 wasused to push the embolic agent 1 all the way to the target tissuesbefore dissociation took place, this final step would not have beennecessary.

FIGS. 8B-C depict embolic agents permitting operator to determine thelength of detached embolized segment with precise operator-determinedplacement near the tip 211 of the introducer catheter 200 withoutrequirement for operator modification, and have mechanical, lockablecomponents. FIG. 8B is a sequential series depicting a lockingdetachable embolic agent 1 using a conventional type of lockingmechanism 10 in a novel series of repeating segments 52. This embolicagent 1 is shaped roughly similarly to most described herein; round incross section and long and narrow. Its body 40 is depicted as amonofilament 5 but in variation it could be a helical wire 33. It hasrepeating segments 52 with locking mechanisms 10. This causes locking ofthe segments together when constrained inside an introducer catheter 200or an introducer sleeve 216. As seen on the left, a two dimensionalfrontal view with a magnified portion shown in exploded view, theembolic agent 1 is constrained within an introducer sleeve 216, and thelocking mechanism 10 locks the repeating segments 52 together. In thesecond figure, a lower perspective view, the embolic agent 1 is seenbeing driven into the introducer catheter 200 by feeder rollers 325 ofthe embolic delivery system 324. Before entering the feeder rollers 325,the embolic agent 1 is restrained in the introducer sleeve 216, in whichit can easily slide forward or backward, but cannot unlock because thecomponents of the locking mechanism 10 are constrained by the walls ofthe introducer sleeve 216. In the third drawing, one segment 52 isnearly deployed in the tissues beyond the distal end 210 of theintroducer catheter 200, but is still locked. The final drawing depictsthe disconnection of the locked elements of the locking mechanism 10 ofthe embolic agent 1 once pushed into the target tissue, where it is nolonger constrained in the introducer catheter 200. Variations of thelocking embolic agent 1 are many, and include a different configurationof locking mechanism 10 that would serve the same purpose, and use ofmany different types of composition materials. As with other embolicagents, the shape and proportions of the system may vary.

FIG. 8C is a sequential view of a lockable detachable embolic agent 1which does not have repeating segments and is modified by the operatorprior to detachment. It permits detachment at any location of theembolic agent chosen by the operator. On the left, an embolic agent 1has already been cut from a very long continuous embolic agent providedby manufacturer, consisting of a flexible tube 55 with a hollow lumen 7,a wall 2, and periodic markers 13, one of which is seen at the proximalend 18. In variation, it could have a reinforced wall as describedherein. In the second drawing, a pusher element 90 has been insertedinto the lumen 7 of the proximal end 18 of the embolic agent 1, creatinga friction lock, and then embolic agent 1 and pusher element 90 havebeen advanced in unison beyond the distal end 210 of the introducercatheter 200. The pusher element 90 consists of a relatively stiff wire100 which may be removably inserted into a long hollow tube 101 whoselumen 97 snugly accommodates the wire 100 as shown, tapers at the distalend 92 so that insertion of the wire 100 to the distal end 92 willresult in very slight increase in outside diameter of the tube 101 tocreate a friction attachment to the lumen 7 of the embolic agent 1,permitting control over the embolic agent by the operator while it isintra-corporeal. The tube 101 of the pusher element 90 has a blunt,closed distal end 92, and is relative stiff, but flexible enough to passaround curves. In the third drawing, the wire 100 has been withdrawnfrom the tubing 101 of the pusher element 90 by the operatorextra-corporeally. Relative stiffness and reinforcement of the tubing101 helps facilitate this maneuver. With the wire 100 removed, thedistal end 92 of the tubing 101 is now more flaccid and is easilyremoved from the lumen 7 of the embolic agent 1, leaving the embolicagent 1 in the desired tissues in the body, while all other componentsmay be retrieved extra-corporeally by the operator as seen in the fourthdrawing.

FIGS. 8D-G introduce a novel linking element 110 which is integratedwith a detachment element 120 containing traction elements 270 forattachment of an embolic agent to a pusher element, which may beinstalled onto the embolic agent by the operator, permittingcustomization of its length and permitting precise detachment near orbeyond the distal end of the introducer catheter. FIG. 8D is aperspective view showing 6 examples of linking element 110 which isintegrated with a detachment element 120 which are bi-directionallocking elements 122, made of a solid, rigid material such as metal orhard plastic, which may be attached to an embolic agent 1 and a pusherelement 90 by the operator, so that the two may be locked together ordetached as desired, functioning similarly as seen in FIG. 8B. Thesediffer from conventional bi-directional locking elements which are notmodifiable by the operator and therefore not allowingoperator-determined length of embolic agent 1 as described for thisinvention. In FIG. 8D, the bi-directional locking elements 122 have anattachment pin 113 which is used to detachably attach to a pusherelement 90 and/or embolic agent 1 as shown in FIGS. 8E-F. Secureattachment is aided by the following traction elements 270 depicted inclockwise direction in FIG. 8D: barbs 273, no traction elements, ridges272, curved attachment pin 113, roughness 271, and threads 276. Rapidcuring adhesive may also be applied by the operator to attachment pin113. FIG. 8E is a longitudinal section view and FIG. 8E-1 is a crosssection view of a linking element 110 which is integrated with adetachment element 120, depicted after attachment to the hollowed outend of the pusher element 90 by the operator extra-corporeally, so thatthe linking element 110 with attachment pin 113, bi-directional lockingelement 122 with pin 113, and the embolic agent 1 may now function asone unit. The linking element 110 is linked to another bi-directionallocking element which is rigidly attached to a pusher element 90, sothat all elements may now act in unison with control by the operatorwhile the linking elements 120 are constrained inside an introducercatheter and thereby locked together similar to depicted in FIG. 8B. Theembolic agent 1, linking element 110, and one of the detachment elements120 are detached from the other detachment element 120 and pusherelement once pushed beyond the end of the introducer catheter. In thelongitudinal view of FIG. 8F and the cross section view of FIG. 8F-1,the bidirectional locking element 122 with pin 113 of the linkingelement 110 is similarly attached to the lumen 7 of a tubular embolicagent 1. Since it is tubular, it does not need to be hollowed out byoperator prior to attachment of its function is otherwise similar toFIG. 8E. The devices in FIG. 8E-F function similarly to the schematicrepresentation in FIG.

FIG. 8G is a sequential perspective views that depict the use of thelinking element 110 which integrates with detachment element 120 ofFIGS. 8D-F in conjunction with an embolic agent 1 consisting of ahelical wire 33, and a pusher element 90 also consisting of a helicalwire 33, and method of use for advancement or retraction and controlleddetachment in conjunction with an introducer catheter 200 and anintroducer sleeve 216. A helical wire embolic agent 1 is seen extendingthrough the entire length of the lumen 209 of an introducer catheter200. This has a hollow space inside 34, although in variations may havea mandrel wire or other agent in its space inside 34. The proximal end18 of the embolic agent 1 is seen, having been severed by the operatorusing cutting tools described herein or being the natural end of themanufactured embolic agent 1. The attachment pin 113 is inserted intothe space inside 34 of the embolic agent 1 and secured using any of themeans described herein. The introducer sleeve 216, which is a rigid orminimally flexible tube with a flared end is advanced over the embolicagent 1 yielding the configuration seen in the second figure in thesequence. Now the pusher element 90 is introduced, with thebi-directional locking element 122 of the linking element 110 secured inits distal end 92, either by the operator, or by the manufacturer. Asshown by the arrow, it is mated with the bi-directional locking element122 attached to the embolic agent 1, as seen in the third figure of thesequence, where it can also be seen that the flared end of theintroducer sleeve 216 has been slid down over the mated elements so asto constrain them in its lumen 209 so they will stay locked together.Now, as indicated by the arrow, the operator may push the pusher element90 forward, while simultaneously advancing the mated embolic agent 1,and the introducer sleeve 216 until the introducer sleeve 216 abuts thehub of the proximal end 206 of the introducer catheter 200. As seen bythe arrow, the pusher element 90 is advanced forward, and as indicatedby the other arrow, the introducer sleeve 216 is now slid down thepusher element 90, out of the figure thus yielding the final drawingwhere the embolic agent 1 is seen inside the introducer catheter 200,where the bi-directional locking elements 122 remain constrained andlocked together. Further advancement (not depicted) will result indeployment of the embolic agent 1 in the target tissues, where nowunconstrained, the locking elements 122 may dissociate and the pusherelement 90 may be retracted and retrieved as described elsewhere herein.

FIG. 8H is a sequential longitudinal section depiction, with explodedview, of another embodiment of a linking element 110 which is integratedwith a detachment element 120 having traction elements 270 which arescrew threads 276. The attachment pin 113 in this example has screwthreads 276 to help it attach to the embolic device 1 which also hascorresponding traction elements 270 of screw threads 276, although anyof the variations of attachment pin shown in FIG. 8D are possible hereas well including rapid curing adhesive, permitting the use of anembolic agent 1 which does not have screw threads. If screw threads 276are used on the attachment pin 113, then they may be oriented in theusual manner, or in the opposite direction as shown, such that it wouldbe tightened using counter-clockwise rotation. This might be done sothat counterclockwise rotation of the pusher element 90, performed withintention to detach it with detachment element 120, will not result ininadvertent loosening of the linking element 110 from the proximal end18 of the embolic agent 1. Extra-corporeally, the operator may firstscrew the linking element 110 into the proximal end 18 of the embolicagent 1, and then screw the distal end 92 of the pusher element 90 intothe detachment element, which has traction elements 270 of screw threads276 to mate with the corresponding screw threads 276 of the detachmentelement 120. When release of the embolic agent 1 into the target tissuesis desired, the pusher element 90 may be rotated counter-clockwise, thusdisengaging it from the detachment element 120 and the linking element110, which stay attached to the embolic agent 1 as it remains in thetarget tissues.

FIG. 8I is a longitudinal section view of another variation of adetachment element 120 and a linking element 110 that offers an overallshape different from a simple straight-line configuration in order tofacilitate nesting into tissues or prevent tissue perforation. Theattachment pin 113 is curved, in this example into a gentle right angle,near its junction with the wider portion that uses screw threads 276 forattachment, although any other traction element 270 described herein maybe used. The attachment pin 113 is flexible and elastic, allowing it tobe straightened when constrained inside the lumen of an introducercatheter (not shown). It will resume its memory shape of the depictedcurve once deployed in the tissues. It may be composed of heat sensitiveNitinol which becomes more rigid after warming to body temperature. Therounded shape minimizes risk of trauma or perforation to tissues.

FIG. 8J is a sequential longitudinal section view depicting a variationof a linking element 110 that is intended to reduce possible trauma tothe wall of a vessel or other body part. On the left, a detachmentelement 120 with the traction elements 270 screw threads 276 one end,integrates with a linking element 110 having an attachment pin 113 withtraction elements screw threads 276. The linking element 110 is shown inexploded view to be inserted by the operator into the proximal end 18 ofan embolic agent 1 that has a wall 2 around a round space inside 34. Onthe right, the assembly is depicted. The curved attachment pin 113imparts a gentle curve to the proximal end 18 of the embolic agent 1when in the resting state with no external forces applied. This may havepositive implications when resting in tissues, where the gentle “J”shaped end is less likely to jut against the tissues and causeperforation. The curved attachment pin 113 is composed of a highlyflexible and elastic compound, such as types of stainless steel orNitinol; however, so that when the depicted assembly is inserted intothe lumen 209 of an introducer catheter 200 (not shown here) asdescribed elsewhere herein, it will straighten out to allow passagethrough the lumen 209. Once deployed beyond the tip of the introducercatheter 200, it will resume its memory shape of a curve as shown.Although the “J” shape is depicted, there are many other shapesconsistent with this invention that will also serve the function ofpreventing a straight-line configuration, and thereby reduce thelikelihood of tissue perforation.

FIGS. 8K,M and N are longitudinal sectional depictions pertaining toembolic agents 1 using threaded detachment elements 120 where thetraction element 270 threads 276 of adjacent detachment elements 120have reversed orientations relative to each other, decreasing idealdistance between detachment points 132, and not requiring modificationby operator prior to detachment. In FIG. 8K, the embolic agent 1 is aflexible monofilament 5 with many interlocking repeating segments 52having the following pattern, from proximal 18 to distal 19: metallicfemale component 135 of detachment element 120 non-detachably attachedto non-metallic monofilament 5 by an attachment pin 121, saidmonofilament 5 then non-detachably attached to the final component ofthe repeating segment 52 which is a metallic male component 134 ofdetachment element 120. Detachment elements 120 utilize the tractionelements 270 of threads 276 for locking of male component 134 and femalecomponent 135 together. Although segments 52 repeat, each adjacentsegment 52 has opposite orientation of the screw threads 276 of thedetachment element 120, and will therefore detach using oppositerotational directions. Therefore, when the operator controls theproximal portion 18 of the embolic agent 1 extra-corporeally, they maychoose which of the next two detachment sites 132 will detach based onwhich direction of rotation is used. FIG. 8L demonstrates that the noveldesign described in FIG. 8K permits the spacing of the distance (labeledas “d”) between detachment sites 132 to be less than the length (markedas L) of the of the introducer catheter 200 when operator intends fordetachment site 132 to be beyond distal tip 211 of the introducercatheter 200, so long as d is greater than ½ L. Shorter segment lengthsmay enable more precise control of embolization. In variation metalliclocking mechanisms would not be present and instead the threads would bemanufactured into the monofilament segments themselves if using asubstance providing sufficient hardness for effective attachment. FIG.8M depicts an embolic agent 1 of similar description as FIG. 8K exceptusing helical wire 33 in FIG. 8M instead of monofilament 5 as in FIG.8K. Like FIG. 8K, the detachment elements 120 on adjacent segments 52have opposite orientation of threads 276 and permit the functionalitydescribed in FIG. 8L. FIG. 8N depicts further variation of FIG. 8M inthat the non-detachably attached female component 135 of FIG. 8N is notpresent, and instead in FIG. 8N the internal surface 54 of the helicalwire 33 function as the female component of the detachment element 120,with similar function as in FIGS. 8K and 8M. Also in FIG. 8N, there maybe weld points 21 in the helical wire 33 at the site of mating with themale component 134 of the detachment element 120 of the adjacent segment52, in order to prevent spreading of the wire coils which might decreasethe strength of the lock. Because the embolic agent 1 will not typicallybe rotated during phase of its advancement through the introducercatheter 200 (not shown), the locking mechanisms 122 may all be securedrather loosely at the time of manufacture, so that little rotationalforce will be required at the time of desired detachment 132.

FIG. 8O is a sequential representation of a detachment mechanism using adetachment element 120 which includes a tube 124, and is used inconjunction with a pusher element 90. The embolic agent 1 hasoperator-determined variable length and infinite choices of detachmentsites 132. The long embolic agent 1 is severed and further modified bythe operator using an embolic detachment tool 160 which narrows theproximal end 18, so that it will fit snugly into the distal end 92 ofthe tube 124 of the detachment element 120. Cutting and modification arenot shown in this figure but are described herein. The first drawing onthe left depicts an optional stabilizer 169 which is an embolicdetachment tool 160 element consisting of 2 flat solid plates with astabilizer groove 170 having friction surfaces, and extendinglongitudinally along the surface of each plate and forming a roundchannel when the plates are pressed together (horizontal arrows) andmerged as shown, to stabilize the pusher element 90 and the embolicagent 1 so that the former can be inserted into the latter (direction ofvertical arrows) without bending or difficulty. Alternatively theoperator will simply use their fingers. Once inserted as seen in themiddle figure, the pusher element 90 can now be used to advance orretract the embolic agent 1 within the introducer catheter (not shown).Detachment 132 is seen in the third drawing on the right. The pusherelement 90, which may be a conventional wire 100 is inserted by theoperator into the lumen 97 of the proximal end 91 pusher element 90 andadvanced until its tip 94 abuts the embolic agent 1. This may providemore stiffness in advancing the embolic agent 1. Once detachment 132 isdesired, the pusher element 90 is advanced while holding the tubing 124static, pushing the embolic agent 1 out of the tip 94 of the pusherelement 90 as shown, showing a wire 100 could be advanced with someforce when it abuts the proximal end 18 of the embolic agent 1, thuspushing the embolic agent 1 out of the tip 125 of the tube 124 and theembolic agent 1 out of the tube 124 thereby detaching it from thedetachment element 120. FIG. 8P is a frontal view depicting an embolicagent 1 that has operator-determined variable length and infinitechoices of detachment points 132 using hydraulic pressure. It is shownwith a pressure generator 172, in this case a syringe 653. Thedescription of device and use is the same as FIG. 8O until the thirddrawing in the sequence, when detachment differs in that hydraulicpressure is used to force the embolic agent 1 out of the tip 125 of thetube 124 thereby detaching it from the detachment element 120.

FIG. 8Q is a 2 part sequential series with 3 dimensional frontal viewsand cross sectional views FIG. 8Q-1 and FIG. 8Q-2 of a detachableembolic system 1, plus a single 3 dimensional view of a variation of thedetachment element 120. It depicts an embolic agent 1 that hasoperator-determined variable length and infinite choices of detachmentpoints 132 when combined with a detachment element 120 using hydraulicpressure differently than FIG. 8P. FIG. 8Q shows, beginning on the left,an embolic detachment element 120 which is a smooth flexible tubecomposed of a polymer, possibly with very fine metal wires reinforcingits wall 136 in a conventional manner, containing a central hollow lumen126 and integrated with a pusher element 90, with a hub 102 on itsproximal end 91. The detachment element 120 has a closed, solid tip 125.The lumen 126 passing through the integrated pusher element90-detachment element 120 is fluid-tight except for the opening at thehub 102 of the proximal end 91, which may be connected to syringe 653for injecting fluid to create increased pressure within the lumen 126.On the distal end 139 a balloon 137 is located, that is in continuitywith the lumen 126 and may therefore be filled with fluid or salineunder pressure, thus expanding its diameter. In an example of avariation seen on the bottom right view a detachment element 120,instead of a balloon, the distal end 139 may simply have a wall 136 thatis composed of a compliant material, while the middle 93 and proximalend 91 of the pusher element 90 are composed of a non-compliantmaterial. In this variation, compliant distal end 139 of the detachmentelement 120 would swell in diameter upon application of hydraulicpressure into the lumen 126, and thus serve a similar purpose as aballoon. The detachment element 120/pusher element 90 may have acombination of rigidity and flexibility that allows pushing aroundbends, and which may have a transition between more rigidity in itsproximal end 91 relative to a more flexible distal end 139. Invariations, it could have a variety of compositions. The figure in themiddle shows the detachment element 120 inserted into the hollow lumen 7of the embolic agent 1 at its proximal end 18, which has been severedusing means described herein, or is the natural proximal end 18 of theembolic agent 1 as manufactured. Then, progressing through the sequenceas indicated by the solid arrow, the hub of the syringe 653 is connectedto the side port 535 of the side-port adaptor 530, and the hub 532 ofthe side port adaptor 530 is attached to the hub 102 of the proximal end91 of the pusher element 90. A conventional pressure manometer may beincluded to provide predictable inflation pressures. In this figure, asmall diameter guide wire 550 is shown extending through the entirelength of the lumen 126 of the pusher element 90 and detachment element120, with its distal tip 552 as shown, and then extending proximally outthrough the lumen 541 of the side port adaptor 530, through its O-ring537, and further proximally into the environment where its proximal end551 is located and available for manipulation by the operator. Thisguide wire 550 represents an optional element that the operator may ormay not choose to advance into position as shown, in order to provideadditional stiffness to the detachment element 120 in order tofacilitate its function as a pusher 90 or retractor of the embolic agent1. Because the O-ring 537 of the side port adaptor 530 may be tightenedaround the guide wire 550, the seal is fluid-tight and pressure maystill be transmitted from the syringe 653 to the balloon 137 or thedistensible distal end 139 of the detachment element 120. Now that allthe connections are secured, fluid or gas is injected by the syringe 653as indicated by the solid arrow, or by other conventional means, togenerate hydraulic pressure in the lumen 126 and the balloon 137. Theballoon 137 [or compliant distal end 139 of detachment element 120 ifdescribed variation is used], is seen to swell in diameter, thuspressing outwardly against the inside of the hollow embolic agent 1,which does not itself stretch substantially radially due to the tensilestrength of its wall 136 reinforcement, providing friction grip. Thismakes the detachment element 120 essentially function also as a pusherelement 90, allowing operator to deposit the embolic agent in the targettissues beyond the tip 211 of the introducer catheter 200, at which timethe pressure can be released from the syringe, or made negative byretraction of the plunger of the syringe, to deflate the balloon 137 orthe distended wall 136 of the distal end 139 of the detachment element120 (depending on whether first embodiment or described variation isused). Detachment element 120 may now be removed. In variation, ahelical wire 33 with a hollow space 34 inside as described herein may beused instead of a tubular embolic agent 1 with same overall effect asdescribed in FIG. 8Q.

FIG. 8R depicts two variations of an embolic agent 1 that hasoperator-determined variable length and infinite choices of possibledetachment sites, using hydraulic pressure to provide turgidity, whilepermitting a hollow lumen 7 throughout most of the embolic agent 1 to beused as part of a variety of detachment mechanisms described in thisinvention. On the left, the embolic agent 1 is a very long tube 55 witha hollow lumen 7, in this case reinforced by conventional helical wire33 imbedded within its wall 2, although other conventional reinforcementstructures used in catheters may be used in this embolic agent 1, wherethe use of a reinforced tubular structure is novel. The greatflexibility of this hollow tube is an advantage for nesting in abnormaltissues, but it benefits from extra stiffness gained from hydraulicpressure during advancement by the embolic delivery system. The tip 57is closed, and the only opening is via the proximal hub 58. It is shownwith a pressure generator 172, in this case a syringe, attached to itsproximal hub 58 with a pressure meter 173 interposed, indicating thepressure in the lumen 7 of the embolic agent 1 created by the fluid 60in the pressure generator 172 and lumen 7. The pressure generator 172may have been applied by the operator at the time of the procedure. Invariation, as seen on the right, there would be no pressure generator172 or pressure meter 173, and instead the proximal end 18, and therebythe entire embolic agent 1, would be packaged by manufacturer with afluid-tight seal throughout, with pressurized fluid 60 filling the lumen7 and providing the optimal pressure for purposes herein. Thepressurization provides turgidity and increased stiffness of the embolicagent 1 so that it may have the desired properties for advancement bythe embolic delivery system (not shown) as described herein. Once thedesired length of embolic agent 1 has been deployed within the body, theembolic agent 1 may be severed extra corporeally creating a new proximalportion with an accessible lumen 7 as described in this invention.Pressure will be lost within the embolic agent 1, however it is nolonger necessary since the last portion will not be advanced using theembolic delivery system 1 but instead will be advanced manually, afterattachment of any of the many detachment elements and pusher elementsdescribed herein. The entire embolic agent 1 is advanced into thetissues, detached, and other elements removed as described in thisinvention.

FIG. 9A includes four frontal sequential views, and many cross sectionviews FIGS. 9A-1 to 9A-4 and 9B-1 to 9B-4 depicting anoperator-controlled linking element 110 that may be used to link a widevariety of embolic agents to a wide variety of types of detachmentelements, providing versatility and broadening of applications for manyelements. On the left, several elements are shown and are included incross section FIGS. 9A-1 to 9A4 before linking as they might beexperienced by the operator in the extra-corporeal operating field.Included is a portion of the embolic agent 1 consisting of anon-metallic monofilament 5 containing a marker wire 13, the linkingelement 110, which in this case is a swage ring 111, a detachmentelement 120, which is electrolytic, and a pusher element 90 whichtransitions imperceptibly with the detachment element 120. The swagering 111 is a metallic hollow ring which is amenable to concentriccompression and deformation, thereby bonding and linking other elementsin its center. At the core of the pusher element 90 and the detachmentelement 120 is an electrolytically corrodible wire 128 which iscontinuous throughout the detachment 120 and pusher 90 elements andavailable for electrical contact proximally in the operating fieldextracorporeally at the contact point 103. In the detachment element120, the wire 128 is surrounded and electrically insulated by adielectric semi-rigid capsule 131. Progressing more proximally, the wire128 is not insulated at the short bare portion 130, which serves as thedetachment point 132. Proximal to the bare portion 130, in itsnon-tapered long portion, the wire 128 is coated with an electricallyinsulating coating 129. Progressing more proximally into the pusherelement 90, the continuous wire 128 remains coated as seen in FIG. 9A-5until its proximal end where there is another bare portion 104 whichserves as an electrical contact 103 to connect to energy source asdescribed in this invention. In the second drawing, the embolic agent 1and the detachment element 120 have both been inserted into oppositeends of the hollow swage ring 111 by the operator in the operating fieldextracorporeally. An embolic detachment tool 160, in this case a swagingtool 171, is then applied providing concentric compression. In the thirddrawing, the swaging tool has been removed, and the swaged elements areseen linked together securely, with compression of the swaging ring 111,the embolic agent 1, and the capsule 131. This is also depicted in crosssection FIGS. 9A-6 and 9A-7. The operator now has complete control ofthe embolic agent 1 by controlling the pusher element 90, and mayadvance or retract the embolic agent 1 at will even when it has passedinto the target tissues in the body beyond the introducer catheter (notshown). When proper position of embolic agent 1 is achieved, theoperator may perform electrolytic detachment. Current may be applied tothe wire 128 extra-corporeally at the contact 103, and opposite polaritycharge may be conducted to the ionic medium around the detachment point132 using methods described in this invention. The fourth drawing showsthe effects of electrolytic corrosion with detachment 132 of thedetachment element 120 into fragments, with the upper fragment remainingnon-detachably attached to the embolic agent 1 and the lower fragmentremaining non-detachably attached to the pusher element 90. The swagering 111 may also serve as a marker 112 of the end of the embolic agent1, especially if a dense metal such as platinum us used.

FIG. 9B is a two part series which includes cross section FIG. 9B-1depicting a variation of the foregoing using a tube-like embolic agent 1with a hollow lumen 7. In the first drawing, the wire 128 of thedetachment element 120 extends distally beyond the capsule 131 as shown,so that when the detachment element 120 is inserted into the swage ring111 as seen in the second drawing, the wire 128 extends into the lumen 7of the embolic agent 1, and serves effectively as a mandrel when swagingcompression is performed as described above (not shown). A marker wire13 is present in the wall of the embolic agent 1.

FIG. 9C is a two part 3 dimensional sequential series with crosssections FIGS. 9C-1 to 9C-8 depicting a variation of FIG. 9A withreduced components and simpler operation by operator in the field. Thecapsule 131 around the corrodible wire 128 in the detachment element 120has been omitted, and a non-corrodible metal is used for the swage ring111. Electrolytic corrosion may still only occur at the bare portion 130detachment point 132. Although other non-corrodible metals could be usedfor the swage ring 111, platinum is used in this figure, and it alsoserves as a radio-opaque marker 112 which will remain non-detachablyattached to the proximal end of the embolic agent 1 after swaging, andafter detachment, thereby allowing the operator to know the position ofthe entire embolic agent 1 upon detachment. In an embodiment, omissionof the capsule 131 may simplify manufacturing. Also seen in the firstdrawing on the left is another variation including the non-detachableattachment of the proximal portion of the swage ring 111 to thecorrodible wire 128. This is shown as having been swaged on, howeverother conventional means such as welding, brazing, soldering, oradhesive could be used. This pre-attachment presents the operator withfewer separate components and a simpler procedure to perform in thefield. The operator will insert the proximal end 18 of the embolic agent1 with marker 13 into the swage ring 111 and apply the swage tool (notshown) to achieve the result in the second drawing, where, as in FIGS.9A-B, the pusher element 90 and embolic agent 1 are securely linked bythe linking element 110 and detachment element 120 until operatorchooses to perform detachment as described in FIG. 9A. In variation ofFIG. 9C, a dielectric coating or capsule around the distal end of thewire 128 of the detachment element, similar to the coating 131 in FIG.9A, may be present to prevent electrical conduction from wire 128 toswage element 111. This would allow use of electrolytically corrodiblemetal for swage element 111, or if non-corrodible metal were used, thecoating would decrease the physical size of the electrode possiblyhastening electrolytic corrosion at the intended detachment point 132.

For FIGS. 9A-C, in variation, a non-corrodible wire may be substitutedfor the coated portion of the corrodible wire 128 to conduct electricityto the bare area 130 of the corrodible wire 128, using conventionalmetal-metal connection techniques. In FIGS. 9A-C, an electrolyticdetachment mechanism was shown simply for demonstration purposes, asnearly any other type of detachment system may be substituted due theversatility provided by this novel linking method. Many other variationsare possible using the linking element described, as almost anydetachment mechanism, including those of this invention as well asconventional or described elsewhere, may be easily envisioned to belinked with nearly any embolic agent by someone experienced in thisfield, thereby providing the novel features of this invention includinga variable-length embolic agent whose length is determined by theoperator during the procedure, and whose overall length may far exceedthose of conventional or previously described agents.

FIG. 9D is a four part sequential series. The first two drawings arelongitudinal sections, and the last two are frontal views withcross-section views depicted in FIGS. 9D-1 to 9D-8. The first drawing onthe left depicts an embolic agent 1 consisting of a helical wire 33,with blunt end pieces 61 on both proximal 18 and distal 19 ends, saidend pieces non-detachably connected to the same straight wire 6, andsaid end pieces also optionally non-detachably connected to the helicalwire 33 at its proximal 18 and distal 19 ends at what will be called theweld points 21 although solder or other conventional means may be used.This configuration permits flexibility of the embolic agent 1 whilepreventing excessive elongation of the embolic agent 1, which may beimportant if retraction is desired by pulling on the proximal end 18.The embolic agent may be composed of corrodible or non-corrodible metalbut will not be subject to electrolytic corrosion due to dielectriclining 114 as will be described. This embolic agent resembles someconventional available agents. In variation, the wire 6 may besubstituted with a non-metallic strand. In the second drawing, theembolic agent 1 has been severed by a cutting tool (not shown) by theoperator in the operating field extracorporeally, when the desiredlength has been determined, cutting through the helical wire 33 and thestraight wire 6. In the third drawing, the severed embolic agent 1 isabout to be inserted into the cup-like opening of the linking element110, which is a swage ring 111 that has been pre-attached non-detachablyto the detachment element 120 as in FIG. 9C. In FIG. 9D, an additionalcomponent is shown, which is a lining 114 made of durable, semi-rigiddielectric material that is placed into the proximal portion 18 of theavailable space within the swage ring 111 at the time of manufacture.Once inserted into the swage ring 111, the proximal end 18 of theembolic agent 1 will abut the plug 116, which is a compressibledielectric material that sits between the embolic agent 1 and the distaltip of the wire 128, thereby preventing current flow from latter toformer. The lining will electrically insulate the embolic agent 1 fromthe swage ring 111 and the corrodible metal wire 128 of the detachmentelement 120. Therefore the embolic agent 1 is not in electricalcontinuity with the wire 128. The fourth drawing shows the assemblyafter swaging by the operator with swage tool (not shown). All elementsare now linked and advancement and retraction of embolic agent 1 isachieved by manipulation of pusher element 90, until desired time todetach using means described in FIGS. 9A-C, including electrolyticdetachment at the detachment point 132 in the bare portion 130 of thewire 128. In variation, the dielectric lining 114 may extend throughoutthe entire inside surface of the linking element 110, thereby providinginsulation between the electrified wire 128 and the swage ring 111,thereby limiting size of electrode to the bare portion 130 of the wire128 to possibly hasten its electrolytic corrosion, and permitting use ofcorrodible metal for the swage ring 111.

FIG. 9E is a series of frontal views of a system and method utilizing alinking element 110 as shown in FIG. 1I. On the left, the distalintroducer catheter 200 is within the body cavity and the proximalportion is extracorporeal. Most of the embolic agent 1 is a tube with awall 2 and a lumen 7 and has been passed into the body cavity, and theproximal portion has been severed using the operator using an embolicdetachment tool 160 (not shown). The distal end 92 of a pusher element90 is attached to a detachment element 120, which in this example iselectrolytic and has a bare portion 130 of corrodible wire 6 which willserve as a detachment site 132, and functions as described in thisinvention. The detachment element 120 is non-detachably connected to thelinking element 110, which is this example is a round, blunt-tippedrigid object with a diameter large enough to fit snugly into the lumen 7of the proximal end 18 of the severed embolic agent 1 withoutsubstantially stretching it. The wall 2 of the embolic agent may bereinforced to help prevent stretching. The linking element 110 isattached by the operator to the embolic agent 1, with attachmentoptionally aided by traction elements 270 or adhesive (not shown). Asseen in the second drawing, the embolic agent 1 has now been pushedentirely into the body by the operator by advancing the pusher element90, with control over advancement and retraction. In the third drawing,detachment has been performed at the detachment point 132, the embolicagent 1 is left in place as the pusher element 90 and part of thedetachment element 120 are removed. In variation, nearly any type ofdetachment element such as mechanical detachment systems describedherein, or conventional systems, may be substituted for the electrolyticdetachment mechanism in this example.

FIG. 9F and cross-section views 9F-1 to 9F-3 depict a system that uses alinking element 110 and electrolytic detachment in a novel manner toenable the novel utilities of this invention. It also demonstrates avariation for electrolysis where by a second separate smaller electricalwire 143 is used to carry current instead of the structural pusher 90.On the left drawing, the very long embolic agent 1, which is composed ofan electrolytically corrodible wire 6 surrounded and insulated by acapsule 43 as described in this invention, has already been severed atthe proximal 18 aspect by the operator as described herein. Aftersevering, a small portion of the capsule 43 at the proximal end 18 wasstripped or burned off or otherwise removed as described herein usingdetachment tools described later herein, leaving a short segment of bare130 wire 128 which constitutes the detachment element 120. The pusher 90is shown here as a dielectric monofilament, although an insulated wireor non-insulated wire could be used so long as it was not in directelectrical contact with the linking element 110 (e.g. separated by adielectric material). A second insulated electrical wire 143 of verysmall diameter passes alongside the pusher element 90 and makeselectrical contact with the linking element 110 which is attached to thepusher element 90. The linking element 110 is a non-corrodible metalsuch as platinum so it will also serve as a radio-opaque marker 13.Alternatively, it may be a corrodible metal so long as it would becoated with insulation everywhere except within the hollow core 115,which is a small round hollow area in the center of at least a portionof the linking element 110 that may receive the wire 128 of thedetachment element 120 on the embolic agent 1 and provide electricalcontact between the two elements. Coating 129 of the linking element 110may be applied in variation even when using non-corrodible metalcomposition in order to prevent inadvertent contact with oppositepolarity electrode contact in an electrolytic introducer catheter asdescribed in this invention. In the center drawing, the operator hasinserted the wire 128 into the swage ring 111 and swaged it to create anon-detachable attachment, and also leaving a short distance between thelinking element 120 and the capsule 131 where a short segment of bareportion 130 of wire is exposed to the surrounding fluids (not shown). Inthe third drawing, the operator has applied current from an electricalsource 176 as described elsewhere in this invention, using a novelelectrolytic introducer catheter described herein (not shown), resultingin corrosion and detachment at the detachment point 132. This figurerepresents a relatively simple yet highly functional detachment systemthat enables variable length embolic agents under full operator controland detachment at the tip of an introducer catheter. Although the use ofthe separate insulated electrical wire 143 could be avoided through useof novel aspects of this invention such as electrified introducercatheters, it is shown here to demonstrate that the linking mechanismopens up possibilities for increased detachment functionality ofvariable length and multiple detachment site options even when usingmore conventional electrolytic means.

FIG. 9G with cross sections 9G-1 to 9C-4 depict a system similar to thatof FIG. 9F however instead of electrolytic means, detachment of theembolic agent 1 may be accomplished with nearly any type of mechanicaldetachment system in this invention or elsewhere similar to the mannerof FIG. 1I. On the left, the embolic agent 1, shown partially within theintroducer catheter 200, is the same as FIG. 9F except the wire 6 neednot be corrodible, and could be a denser metal serving as a marker 13 asseen in cross section FIG. 9G-1. Cross section view FIG. 9G-2 shows Thelinking element 110 with hollow core 115 of FIG. 9G which is similar tothat in FIG. 9F except in the absence of electrification in this system,this element and all others may have composition and interfaces withoutregard to electrical concerns. The linking element 110 is non-detachablyattached to a detachment element 120. This detachment element is similarto the interlocking bidirectional mechanism described herein but in thisembodiment is mainly used to denote nearly any variety of mechanicaldetachment system. The second part or the detachment element 120 isnon-detachably attached to the pusher element 90. The second figureshows the array of elements all now securely linked together whileconstrained within the lumen 7 of the introducer catheter 200. The thirddrawing shows detachment 132 when desired by operator when detachmentelements 120 are pushed beyond the tip 211 of the introducer catheter200. Replacement of the depicted mechanical element with many othertypes of mechanical detachment system could be accomplished by someoneskilled in the art using conventional means.

FIG. 10A depicts one embodiment of a novel detachment system usingchemical means. On the left is a flexible embolic agent 1, round incross section depicted in FIG. 10A-1, composed of a strand ofbiocompatible material, in this case a monofilament 5 which is amenableto dissolution in biocompatible solvent such as dimethyl sulfoxide(DMSO). This monofilament 5 is surrounded by a capsule 43 ofbiocompatible material which is not subject to dissolution in the samesolvent. The embolic agent 1 is composed of repeating segments 52 withbare areas 39 of non-encapsulated monofilament 5 exposed to theenvironment. The tip 211 of the introducer catheter 200 is positioned inthe body cavity (not shown) to be treated and the embolic agent 1 isadvanced to near completion into the cavity. There is one bare area 39inside the lumen 209 of the introducer catheter 200. A side port adaptor530 is connected to the introducer catheter 200 in conventional mannerto allow injection of liquid solvent 144 from an attached syringe 653into the side port adaptor 530, where it may flow into the lumen 209 ofthe introducer catheter 200. A precisely measured volume of solvent 144is injected, corresponding to the known void space of the lumen 209 ofthe introducer catheter 200 and side port adaptor 530, in order to fillthe introducer catheter 200 nearly to its tip 211, thus bathing the barearea 39 with solvent. After an adequate dwell time, the figure on theright depicts dissolution of the bare area 39 and subsequent detachment28 of the embolic agent 1 into distal 19 and proximal 18 fragments. Thesolvent may be aspirated, and the distal embolic agent 1 fragment may bepushed by the proximal fragment or by a pusher (not shown) to depositcompletely within the body cavity. This embolic agent 1 and detachmentsystem offers function similar to shown in FIG. 1G in a system that maybe simple to produce at low cost, and simple to use. In variation,instead of a monofilament 5, a polyfilament may be used with similareffect.

FIG. 11A is a series of drawings representing general types ofdetachment mechanisms that have been previously reported. They arereviewed briefly here to illustrate one of the novel concepts of thisinvention, regarding the use of a linking element to enable theapplication of conventional detachment mechanisms for use with avariable-length embolic agent, whereas previously conventional agentswere confined to manufacturer pre-determined lengths when similardetachment elements were used, as in FIGS. 1E-F. In the inventiondisclosed herein, variable-length systems as seen in FIGS. 1I-K are madepossible when using the conventional mechanical detachment systems ofFIG. 11A, or when using novel detachment systems described in thisinvention. In each example in FIG. 11A-11C, there is a point ofnon-detachable attachment 654 to an embolic agent (not shown) in aconventional system, or to a linking element (not shown) as in thisinvention, said linking element being non-detachably attached to adetachment element 120, and said detachment element 120 detachablyattaches to a second detachment element 120 which is integrated with apusher element 90. Referring back to FIG. 11A, detachment of the twodetachment elements 120 occurs, from left to right in the examples, whena wire 128 is retracted making room for the detachment element 120 topass beyond a narrowing in the tube 124 of the detachment element 120,when hydraulic pressure is applied into the lumen 126 of the tube 124 ofthe detachment element 120, when the two detachment elements 120 arepushed beyond the tip of the tube 124 and unhooked from each other, orwhen the two detachment elements 120 are unscrewed from each other.Other types of detachment elements are previously reported and not shownhere, but are nevertheless amenable to adaptation using this inventionas described.

FIG. 11B and cross section 11B-1 are a representation of a detachmentsystem using heat sensitive glue which may be used in a novel mannerwith this invention by combining with a linking element (not shown), anda novel electrified introducer catheter as shown in FIG. 12I, enabling avariable length embolic agent (not shown). On the left, a pusher element90 is non-detachably attached to a detachment element 120, containing acup 141 with heat sensitive glue 140 in its bottom, thereby creating adetachable attachment to the attachment pin 121 of the second part ofdetachment element 120, which has a point of attachment 654 to theembolic agent (not shown) of a conventional device as in FIGS. 1E-F, orthe linking element 110 in this invention with configurationsrepresented by FIGS. 1I-K. The cup 141 is of a dielectric material witha high melting point, and has a heating element 181 in its solid portionwith sufficient electrical resistance to become warm enough to melt theglue when charge is applied. The Wire 128 passes to the outer layerswhich are two conductive metal contacts 133 that that are insulated fromeach other by a layer of dielectric material 142. These contacts 133come into contact with the electrical contacts 221 of the introducercatheter, said contact 221 being attached to an electrical wire 220(catheter not shown, wires schematically represented). Thisconfiguration of the introducer catheter 200 is seen in more detail inFIG. 12I. In the figure on the right, applying electrical energy (notshown) to the wires 220 of the introducer catheter 200 will heat theglue 140, melt it, and allow the attachment pin 121 to detach, therebyreleasing the embolic agent 1 (not shown). Non-detachable attachment ofthe detachment element 120 to a linking element 110 (not shown) at thepoint of attachment 654 as described in this invention, along with theelectrically active introducer catheter 200 will enable an operatorcontrolled variable-length embolic agent with full control of embolicagent via control of pusher element 90 extra-corporeally. FIG. 11Cdepicts a variation where there is only one electric wire 220 and oneelectrical contact 221 in the introducer catheter 200, and the circuitis completed by having the electric wire 128 of the detachment element120 complete a circuit with the electric wire 100 of the pusher element90, so that the proximal end (not shown) of the pusher element 90 in theoperating field can become the second point of electrical contact 133with the energy source. Otherwise the use and effect is similar to FIG.11B. This system could use a single-electrode introducer catheter suchas shown in FIG. 14B, although used differently than depicted therebecause the second electrode would be connected to the contact 133 ofthe pusher element 90 instead of to the skin.

FIGS. 12A-H describe various types of introducer catheters 200containing two electrodes that have novel functionality with regard toelectrolytic detachment of embolic agents. Conventional electrolyticdetachment mechanisms do not incorporate electrolytic ordetachment-related functions into the introducer catheter, which limitsthe function of the detachment mechanism. For example, the ability tocombine controlled detachability with an operator-determined variablelength embolic agent is limited. The use of wires 220 and contacts 221in the introducer catheter 200 will provide functionality that is notpossible with conventional systems that incorporate the conductiveelements on the body of the embolic agent or its detachably attachedpusher element, said conventional systems not having the versatility ofthis novel disclosed system to use embolic agents that may undergodetachment at a single chosen point from amongst a plurality of possiblepoints along its length, thus enabling the use of very lengthy embolicagents that are disclosed herein and in keeping with the spirit of thisinvention including the treatment of large abnormal cavities. FIG. 12Idescribes an introducer catheter 200 also having anode and cathode bothincorporated into the catheter body, however not intended forelectrolytic detachment, and instead with both electrodes making directcontact with electrical contacts on other elements related to detachmentmechanisms that involve electrification.

FIG. 12A with cross section views FIGS. 12A-1 and 12A-2 show anintroducer catheter 200 with a hub 201 on its proximal end 206, a middle207, a distal end 210, a wall 208 and lumen 209, and is flexible, yetremains pushable as described elsewhere herein for all other introducercatheters 200. It may have more complex architecture to provide idealphysical properties in keeping with conventional systems. Novel elementsinclude electrically conductive wires 220 that are exposed to theenvironment at the hub 201 where they may be connected to external wires174 that connect to a source of DC current 176 such as a battery. Theelectrically conductive wire 220 on the left passes, insulated, throughthe dielectric wall 208 of the catheter to its distal end 210 where itthen comes in contact with the lumen 209 at a point called theelectrical contact 221, where it will contact the corresponding contactpoint of an embolic agent as seen in later figures. The contact 221 maybe composed of a noble non-corrodible metal so that it does not diminishduring electrolysis, thereby maintaining full contact until detachmenthas occurred at the designated detachment point. The opposite pole ofthe power source 176 connects the second electrically conductive wire175 to the electrically conductive wire 220 on the right, of oppositepolarity 231, which then passes insulated in the wall 208 of theintroducer catheter 200 to reach the second electrical contact 221 ofopposite polarity 231 at the distal end 210, which is not directly incontact with the bulk of the lumen 209 or the contact of the embolicagent (not shown). Instead, it contacts the ionic fluid such as blood orsaline solution (not shown) in the lumen recess 223 in which ionic fluidor blood will be present. This will support electrolytic corrosion ofthe corrodible portion of the embolic agent as depicted in many forms inthis invention. The embolic agent (not shown) has an outer diameter veryslightly smaller than the inner diameter of the introducer catheter 200so cannot directly contact the recessed contact 221 of opposite polarity231 on the right, preventing short circuit.

FIGS. 12B-E depict cross sections of variant introducer catheters 200that provide roughly similar function as described for FIG. 12A. In eachfigure, the drawing on the left represents a distal location 210 on theintroducer catheter 200 and the figure on the right represents a middlelocation 207. In FIG. 12B, the distal end 210 of the introducer catheter200 has a contact 221 that occupies a large portion of the lumen 209within its wall 208 as shown, to provide extensive contact with thecontact on the embolic agent (not shown). As in FIG. 12A-1, the secondcontact 221 of opposite polarity 231 is recessed within the lumen recess223 within its wall 208. As shown in the figure on the right, in themiddle portion 207 of the introducer catheter 200, the correspondingwires 220 for each polarity are seen coursing insulated within the wall208. FIG. 12C is similar to 12B except that multiple wires 220 are usedfor each polarity converging onto their respective contacts 221. Thismay permit the use of smaller sized wires 220 or the wires may bestructured so as to also provide stiffness and support properties to theintroducer catheter 200 that are desired. In this example, the first 4wires 220 in the clockwise direction beginning with the 12 o'clockposition service the recessed contact 221 of opposite polarity 231 fromthe other wires 220 which service the contact 221 on left. FIG. 12Dshows a variation whereby there are multiple contacts 221 in continuitywith the lumen 209, each with its own wire 220, and there are multiplerecessed contact 221 of opposite polarity 231 in lumen recesses 223,each contact 221 also being connected to its own wire 220. FIG. 12Edepicts a variation whereby there are multiple wires 220 per contact221, and the contact 221 on the left is in contact with a large portionof the lumen 209, while contact 221 of opposite polarity 231 on the leftis crescent shaped and recessed in the lumen recess 223 with a portionof wall 208 in the middle 208 that prevents direct contact betweenelectrified embolic agent 1 and contacts 221, which instead contact theionic fluid or blood bathing the area.

FIG. 12F with cross section FIGS. 12F-1 to 12F-3 are a sequence view ofa different embodiment of a two-electrode introducer catheter 200showing an example of the detachment process. The introducer catheter200 has, within its wall 208, a wire 220 for one polarity and anotherwire 220 of opposite polarity 231 that end in respective contacts 221near the tip 211 of the catheter as shown. The contact 221 of firstpolarity 230 is circumferential and protrudes very slightly into thelumen 209, to increase surface contact with contact 36 on the embolicagent. Therefore the second contact 221 of opposite polarity 231 is at adifferent level within the catheter, closer to the tip 211 of theintroducer catheter 200, and is recessed within the circumferentiallumen recess 223 containing ionic fluid or blood. Said contact 221 maynot directly contact the embolic agent but is in close proximity. Theembolic agent 1 is similar to that described in FIG. 6P except thedistal marker 13 is located slightly more distally as shown, is one ofseveral novel types described herein that could be used in this system.It has a monofilament 5, and an electrically corrodible wire 6 whichalso forms a connector 35. The embolic agent 1 has an outer diameterthat is very slightly smaller than the inner diameter of the introducercatheter 200. The power source and external wires are not depictedbecause they are similar to those depicted in FIG. 12A, where wires exitthe proximal end 206 of the introducer catheter 200 to contact withwires 175 from the power source 176. When DC power is applied, thecircuit is as follows: power source to wire 220 to contact 221 of firstpolarity 230 to contact on embolic agent 1 (non-corrodible metal) toconnector 35 (electrolytically corrodible metal), through ionic solutionto contact 221 of opposite polarity 231 to wire 220 of opposite polarity231 to power source. Electrolytic corrosion occurs at the connector 35which becomes the detachment point 28. The distal fragment of embolicagent 1 remains in the target tissues (not shown) and the other elementsare removed. The proximal fragment of embolic agent 1 may be used as apusher to push the last few millimeters of embolic agent 1 out of theintroducer catheter 200. Since the embolic agent has a series ofconnectors 35, the operator may choose which site will become thedetachment point 28 without any modifications of the embolic agent 1 bysimply positioning the chosen site at the level of the contacts 221 inthe introducer catheter 200.

FIG. 12G and FIGS. 12G-1 to 12G-3 depicts various views and crosssections of a similar electrolytic introducer catheter 200 seen in FIG.12F, but with minor modifications and using a smaller diameter embolicagent 1 of a different type. The system is shown after electrolyticcorrosion of the embolic agent 1 at the detachment point 28 has alreadyoccurred in the manner described in this invention. The embolic agent 1is an electrolytically corrodible wire 6 with an insulating coating 31over most of it, except in the bare area 39 which is positioned to be incontact with the proximal contact 221 and in close proximity to thedistal contact 221 of opposite polarity 231 in the lumen recess 223 ofthe introducer catheter 200. The power source and external wires are notdepicted as they are similar to those shown in FIGS. 12A-F, whereelectrical wires 220 exit the proximal end 206 of the introducercatheter 200 to contact with wires 174 from the power source 176.

FIG. 12H and cross section FIGS. 12H-1 and 12H-2 show an embodiment ofthe introducer catheters 200 with both electrodes incorporated, with oneelectrode making physical contact with the embolic agent 1 and the othercontacting the body fluids or ionic flush solution. Introducer catheter200 has two electrical wires 220 imbedded in its wall 208, insulatedfrom the environment and the lumen 209. One wire 220 ends in theproximal one of the two contacts 221, and the contact 221 is concentricand protrudes slightly into the lumen 209 to make contact with thecorresponding contact 221 on the embolic agent 1. The other wire 220 isof opposite polarity 231, and is helically wound in the wall 208 of theintroducer catheter 200 to provide structural functions as well aselectrical. The other contact 221 of opposite polarity 231 is located onthe outside of the wall 208 of the introducer catheter 200 and willcontact body fluids, tissues, or ionic flush solution. The proximal endsof wires 220, which are not shown but are similar to those depicted inFIG. 12A, exiting the introducer catheter 200 proximally and contactingthe wires 220 of the power source 176 for both electrodes. The embolicagent 1 in this example is described in detail in FIG. 6S and has acontact 36 which contacts the contact 221 on the introducer catheter200, said contact 36 also contacting the connector 35 which iselectrolytically corrodible and does not conduct to the embolic segment52 distal to the detachment site 28 at the bare area 39. When DC currentis applied, electrolysis will occur at the detachment point 28 of theembolic agent 1 as described herein.

FIG. 12I and cross section FIGS. 12I-1 to 12I-3 depicts an introducercatheter 200 with both electrodes in its structure, but is notstructured for electrolytic detachment and instead enables other typesof detachment by making direct physical and electrical contact of bothof its electrodes with corresponding contacts 221 on the embolic agent 1or its related detachment 120 or pusher 90 elements (not shown). In thisexample, it is shown to be used to facilitate the creation of heat inorder to cause detachment 28 through melting of metal, solder,heat-sensitive glue, or heat sensitive electrically conductive glue. Thedepicted introducer catheter 200 has two wires 220 imbedded in its wall208, one on the left of opposite polarity 231 from the other on theright. Each wire 220 exits the introducer catheter 200 and connects to apower source as described for FIG. 12A and FIG. 12H. Both wires lead tocontacts 221 which protrude slightly into the lumen 209 and physicallycontact the embolic agent 1 which is a wire 6 that is composed of anelectrically conductive metal with a relatively low melting point thatis above body temperature. When power is applied, current will flowpredominantly through the short segment of metal in the wire 220 betweenthe contacts 221 of the introducer catheter 200 at the detachment point28, resulting in detachment as shown in the second drawing. The wire 6in this area will have a sufficient electrical resistance that resultsin generation of adequate heat to quickly melt the metal. Thisembodiment may also be used with the detachment system depicted in FIGS.11B and 12J.

FIG. 12J shows two embodiments of embolic agents that may be used withthe introducer catheter 200 in FIG. 12I. The first two drawings depictthe same embolic agent 1, exploded on the left and non-exploded in themiddle view. The embolic agent 1 includes a series of repeating segments52, each with a proximal end 18 and a distal end 19. Composition of theembolic agent 1 is a conducting metal or metalloid. On the distal end 19of each segment 52 is a protuberance 279, shaped like a cone, whichmates with a depression 280 in the proximal end 18 of the abuttingsegment 52 providing electrical contact between the segments 52. On theflat portion of the mating surfaces, heat sensitive glue 140 or solderis present, which is preferably conductive but not necessarily so. Inthe middle drawing, the embolic agent 1 is seen intact functioningphysically as a unit, and the locations of the contacts 221 and wires220 of the introducer catheter 200 are shown schematically. When currentis applied, it passes through the metal embolic agent 1 between thecontacts 221. The composition of the embolic agent 1 in this locationprovides sufficient electrical resistance to generate heat that meltsthe bond, allowing the segments 52 to separate. The drawing on the rightshows a variation where there is a small gap between the segments 52filled by a small amount of solder or conductive glue 140 which willmelt when current is applied, resulting in separation of the segments52.

FIGS. 13A-E depict electrolytic introducer catheters 200 that includeone electrode within their structure. In some uses, the embolic agentand related elements function as the other electrode for completing thecircuit. In other uses, the electrode in the catheter may be used toprovide current to an area of the embolic agent or related detachmentelements focally near the tip of the catheter without electrifying along segment of embolic agent, thereby providing the novelfunctionalities of this invention. In FIG. 13A and cross section FIGS.13A-1 and 13A-2, one electrode from a power source 176 connects to wire174 at or near the hub 201 of introducer catheter 200 which connects tothe wire 220 helix imbedded in the wall 208 of the introducer catheter200, said wire 220 coming into contact with the contact 221 near the tip211 of the introducer catheter 200, where the contact 221 ends in alumen recess 223 communicating with the lumen 209. There it is inproximity with, but may never physically touch, the embolic agent 1 dueto smaller diameter of recess 223. Although many different embolicagents could be used with this introducer catheter 200, the catheter inthis embodiment is described in detail in FIG. 6K. The operatorpositions the embolic agent 1 so that the bare area 39 is near the tip211 of the introducer catheter 200. The hub 201 of the introducercatheter 200 is located extracorporeal of the patient body while the tip211 and a substantial portion of the embolic agent 1 are located in ornear the target tissues (not shown). The second wire 175 from the powersource 176 is connected to the bare portion 39 on the proximal end 18 ofthe embolic agent 1. In this example, there is another bare area 39 seenproximal to the hub 201 of the introducer catheter 200, howeverelectrolysis will not occur here because it is not in contact with bodyfluids or ionic flush and is open to the air of the operating field.Therefore, the conductive wire 6 of the embolic agent 1 will be ofopposite polarity 231 than for the introducer catheter 200. When currentis applied, electrolytic corrosion will occur at the bare area 39 nearthe tip 211 of the introducer catheter 200, which is in the body (notshown), and detachment will occur at the detachment point 28. Thisvariation of introducer catheter 200 permits the use of many embolicagents 1 for some of the objectives of this invention, for exampleenabling the use of a very long, operator-determined length of embolicagent 1 with controlled detachment 28 near the tip 211 of the introducercatheter 200.

FIGS. 13B-C and cross section FIGS. 13B-1 to 13C-1 show views ofvariations of electrolytic introducer catheters 200 that include oneelectrode within its structure. The distal ends 210 of the introducercatheters 200 are depicted. In FIG. 13B, the electrical wire 220, as inFIG. 13A, is helically wound within the wall 208 of the introducercatheter 200 and makes contact with contact 221 at the tip 211 of theintroducer catheter 200, which in turn makes contact with the bodyfluids, tissue, and flush solution inside the body (not shown). Theembolic agent 1 in the lumen 209 of the introducer catheter 200 issimilar to the one shown in FIG. 6W where it was described in moredetail. Briefly, it has a corrodible wire 33 with a coating 31 and iscomposed of segments 52 that are connected by connectors 35 which arecomposed of dielectric material. As shown in FIG. 13A, it has a barearea in the operating field extra-corporeally where the opposite pole ofthe power source may be connected (not shown). When current is appliedto the wire near the hub of the introducer catheter (not shown) and tothe extracorporeal contact on the embolic agent (not shown), the contact221 of the introducer catheter 200 serves as an electrode, and the barearea 39 of the embolic agent 1 wire 33 will serve as the electrode ofopposite polarity 231. Electrolysis will result in corrosion anddetachment at the detachment point 28 as there are no other bare areasmore proximally and current will not flow more distally than thevisualized connector 35 because it is a dielectric 30. The position ofthe contact 221 could potentially allow direct contact between thecontact 221 and the distal portion 19 of embolic agent 1 that is alreadydeployed into the target tissues, which will often touch the tip 211 ofthe introducer catheter 200. This could create a short circuit, so onlyembolic agents which are insulated, non-conductive, or non-electrifieddistally to the detachment point, such as the depicted embolic agent 1,would be used with this variation. FIG. 13C shows a variation of FIG.13B where the contacts 221 of the introducer catheter 200 are imbeddedin the wall 208, with side holes 217 extending from the contact 221 tothe outer surface 232 of the wall 208 of the introducer catheter 200.Other aspects of the description of the introducer catheter 200 are thesame as for FIG. 13B. The embolic agent 1 shown in this embodiment isthe same as the one described in detail in FIG. 6X, although manyembolic agents described herein would also work with this system. Whenthe power source wires (not shown) are connected to the introducercatheter 200 and the embolic agent 1 extracorporeally, electrolysis willoccur with corrosion at the intra-corporeal bare area 39 of theconducting corrodible wire 6 which is surrounded by insulating coating31 everywhere intra-corporeally except the bare area 39 which wascreated by the operator using detachment tools (not shown and asdescribed elsewhere in this disclosure) and will result in detachment ofthe embolic agent 1 at detachment point 28. In this example, the sideholes 217 are too small to allow embolic agent 1 which is already coiledin the target tissues (not shown) around the tip 211 of the introducercatheter 200 to touch the contact 221. Therefore, a short circuit willnot occur even if there are un-insulated conductive portions of embolicagent 1 distal to the detachment point 28, which could be aconsideration with other embodiments of embolic agent.

FIG. 13D shows another variation where introducer catheter elements andembolic agent elements serve as both electrodes for electrolyticfunction. The introducer catheter 200 has one wire 6 serving one contact221 near the tip 211, said contact recessed away from the lumen 209 in alumen recess 223, contacting the blood or flush fluid (not shown)present in the lumen 209, which also bathes the embolic agent 1 in thisarea. The embolic agent 1 is the same as shown in FIG. 6I but is shownin its modified state, whereby a short bare area 39 has been created byremoving a short segment of the coating 31 as described herein, causingthe detachment point 28 where electrolytic corrosion will occur oncepower is supplied to the wire 220 of the introducer catheter 200 asdescribed in FIG. 13A, as well as to the wire 6 in the embolic agent 1at a bare portion in its proximal portion in the operating field, (notshown) similar to as that described in FIG. 13A and elsewhere herein.

FIG. 13E and cross sections FIGS. 13E-1 and 13E-2 depict an embodimentof introducer catheter 200 similar to that shown in FIG. 13D, exceptwith addition of electrically insulating one-way valves 203 which areused to create a small local environment within the introducer catheterfor electrolytic corrosion while dampening the flow of current tosurrounding fluids and tissues where secondary corrosion of other bareareas of corrodible metal could otherwise occur. Reference to FIG. 13Dshould suffice for explanation of other elements of introducer catheter200 of this variation in FIG. 13E. The embolic agent 1 is described indetail in FIG. 6F, and includes a corrodible helical wire 33 withcoating 31, with uncoated bare areas 39 in multiple locations andradio-opaque markers 13. The valve 203 is, in this embodiment, aconventional semi-rigid non-porous elastic compound, such as latex orsilicone or other compound with similar characteristics, capable ofproviding a substantially fluid-tight seal around the embolic agent 1near the tip 211 of the introducer catheter 200, with said valve 203located in a recess 223 in the internal wall 208. This valve 203 is around leaflet shaped to permit flow from proximal to distal but not inthe opposite direction. It will permit the passage of the embolic agent1 in the usual manner. The valve 203 provides sufficient seal withoutoverly obstructing longitudinal motion of the embolic agent 1. There aretwo valves 203, one proximal and one distal to the recessed contact 221where electrolysis may take place. The valves are sufficientlyelectrically insulating to prevent substantial electrolytic effect orcorrosion of bare areas 39 of corrodible embolic agent 1 that may existin the proximal introducer catheter 200 or distal to the tip 211 of theintroducer catheter 200 in the target tissues (not shown). This helps todirect electrolysis of the corrodible embolic agent 1 to the desiredsite indicated for detachment point 28. Effective isolation of the smallvolume of ionic flush solution which is electrified for electrolysis mayimprove the results when using very simple varieties such as uncoatedcorrodible wires or those with multiple bare areas that are allelectrified such as in this example.

FIG. 13F depicts a section of a dual lumen introducer catheter 200allowing for insertion of a conductive wire 128, which is a detachmentelement 120, into the additional lumen 218 similar to the manner inwhich a guide wire or embolic agent 1 is inserted in conventionalcatheters. The conductive wire 128 is connected to the power source inthe operating field (not shown), and the conductive wire 6 of theembolic agent 1 in the lumen 209 is connected to the opposite electrodeas seen in FIG. 13A. The embolic agent 1 was described in detail in FIG.6J. It has tape 45 sealing the bare areas 39 as manufactured, and hasbeen modified in this example by the operator who has removed the tapein one area, leaving a bare area 39 at the planned site of detachment28. This introducer catheter 200 has advantage of simplicity of designand manufacture.

The series of embodiments in FIGS. 13A-F provide rapid electrolyticdetachment of embolic agent 1 using 1 electrode as an integral part ofthe introducer catheter 200, or inserted into a second lumen 218 of amodified catheter 200. Many different types of the embolic agents whichare not shown in FIGS. 13A-F but are described in this invention arecompatible with these systems and can be used in variation. Otherpossible embodiments could include different configurations of wires orcontacts so long as the main electrolytic process remains intact.

FIGS. 14A-B depict two variations of electrolytic detachment systemsthat apply one electrode to the skin of the body 580 and the otherelectrode to the conductive wire in the embolic agent 1. FIG. 14A is alongitudinal section and with FIG. 14A-1 cross section view of anintroducer catheter 200 and embolic agent 1, with a schematic drawing ofpower source 176 and skin pad 227. This introducer catheter 200 does nothave electrolytic components integrated within it and is essentially aconventional introducer catheter. The embolic agent 1 is described indetail in FIG. 6U. Other embolic agents in this invention would workwell with this system as well. The wire 174 from the power source 176 isconnected to a conductive skin pad 227 which is applied to the skin onthe body 580. The second wire 175 of opposite polarity 231 from thepower source 176 is connected to the wire 6 of the embolic agent 1 atthe proximal end 18 in the operating field as described herein. The barearea 39 of the embolic agent 1 where there is no capsule 43 or coatingis positioned at the tip 211 of the introducer catheter 200 that iswithin the target tissues (not shown). Not visualized here are bareareas beyond the tip 211 of the introducer catheter 200, alreadydeployed in the target tissues which will not undergo electrolyticcorrosion because the wire 6 in the embolic agent 1 is not continuousfrom segment 52 to segment 52, and are insulated by the dielectriccapsule 43. This configuration of electrolytic wiring and its use incombination with the novel embolic agent 1 shown, as well as many othernovel agents described herein, provide novel functionality including thepotential for use with very long embolic agent 1 whose length isvariable and determined by the operator intra-procedurally withdetachment at an operator-determined location such as the tip 211 of theintroducer catheter 200.

FIG. 14B and cross section view FIG. 14B-1 show an embodiment ofelectrolytic introducer catheter 200 with a different type of electricalcontacts 221, which are pliable and flexible and have a bias towards thecenter of the lumen 209 which keeps them in constant contact with theembolic agent 1 even if its diameter is smaller than the lumen 209, orif its diameter shrinks due to corrosion as could occur in the event ofa corrodible contact 36 on some variations of embolic agent 1. Thecontacts 221 are positioned in a circumferential lumen recess 223 may beleaflet-like, as depicted, or may be similar to very fine wirebrushings. This depiction includes the embolic agent 1 described in FIG.6S, which has non-corrodible contact 36 which also serves as aradio-opaque marker 13, and the helical wire 33 is has a coating 31. Theconnector 35 of the embolic agent 1 is corrodible and electrified viathe contacts 36 of the embolic agent 1. Current flows through the wires174 of the power source 176 to the introducer catheter 200 wires 220which pass current to the contacts 221, passing current to the contact36 of the embolic agent 1, then to the connector 35 which corrodes anddetaches at the detachment point 28. The other electrode of the powersource is connected by wire 175 to the skin pad 227 on the skin of thepatient body 580. In variation, a needle may be used instead of a skinpad 227. These brushing type or leaflet type contacts 221 of theintroducer catheter 200 could be used in any of the variations ofintroducer catheters 200 described in this invention that have contactsthat directly contact the embolic agents. In one embodiment, the lumenrecess 223 may not be circumferential, or may be unilateral, so long asconstant contact with embolic agent 1 is maintained.

FIGS. 15A-B are depictions of two embodiments of venting catheters whichmay be helpful to prevent over-pressurization of an aneurysm cavity(also referred to as a “sac”) when inserting a volume of material intoit as occurs with this invention. If there are no pathways for egress ofblood from the sac during embolization, pressure could build up unlessventing occurs through the catheter, thereby preventing complicationssuch as rupture during the procedure. The other benefit of the ventinglumen is to allow injection of fluids such as flush or contrastmaterial, and in some examples to allow passage of small transducerprobes to measure pressures directly in the cavity. FIG. 15A shows anintroducer catheter 200, which is a venting catheter because it has anadditional lumen 218 as well as the lumen 209 used for other purposesdescribed herein. Catheters with multiple lumens are alreadyconventionally available, and in this example we describe a novelconfiguration and combination with other elements that are well suitedfor the objectives of this invention. The additional lumen 218 may besmall because its purpose of venting fluid may still be served, and itsshape in cross section may be irregular as shown in order to keep theouter diameter of the introducer catheter 200 as small as possible. Thislumen 218 communicates with the side port 212, which will accept asyringe, tubing, or other conventional elements. This example embodimentalso shows a pressure transducer 655 integrated within the introducercatheter 200 at its tip 211, to sense the pressure within the aneurysm582 and provide feedback to prevent over-pressurization. The transducer655 connects to a wire 220 in the wall 208 of the introducer catheter200 which exits near the hub 201 and will connect to a monitor (notshown). FIG. 15B shows a variation whereby a transducer 655 is notintegrated into the catheter, but may be inserted into the additionallumen 218 or removed at will. When inserted, it may be near the tip 211of the introducer catheter 200 to sense the pressure in the aneurysm582. Alternatively, the hub 201 corresponding to the additional lumen218 may be connected to conventional tubing (not shown) which may beconnected to an extracorporeal pressure transducer 655, wherebypressures may be measured in this other conventional manner. In thisexample embodiment, the additional lumen 218 is round in cross sectionto accommodate a transducer 655 on a wire 656, or conventional guidewires or other conventional accessories which are typically round incross section. Also depicted are multiple side holes 217 in the wall 208opening the additional lumen 218 to the local environment, in this casethe aneurysm 582. These may help maintain communication of the lumenwith the local environment since end-holes may sometimes occlude orbecome covered by tissue. As depicted in FIGS. 15A-B, these ventingcatheters may be used on combination with a second introducer catheterof smaller diameter (not shown) that may be inserted co-axially throughthe main lumen 209. This could include micro-catheters, which a nameoften is given to small diameter catheters that pass co-axially throughother catheters. Alternatively, minor conventional modification of theseventing catheters with a hemostatic valve (not shown) on the hub 201corresponding to the main lumen 209 could convert them to an introducersheath which could be used in a similar manner of permitting co-axialintroduction of an additional introducer catheter (not shown).

FIG. 16A is an overhead view, with a side view of select elements, of anembolic delivery system 324 that pushes the embolic agent 1 using feederrollers 325. The components of this system are all derived fromconventionally available mechanical parts, which are arranged in thenovel manner shown to provide the novel functions described in thisinvention. The simple nature of this figure will suffice to teach thissystem and method since the individual components are well known in theart of non-medical systems such as wire feeders and other automationdevices. This embolic delivery system 324 includes a drive pulley 331, adrive shaft 332, a hand crank 335, a timing belt 328, a tensioner pulley343, two timing pulleys 379, two feeder rollers 325, and pulley shafts336 for each pulley. The timing belt 328 has teeth that mesh withcorresponding teeth on the timing pulleys 379 to provide a more precisesynchronization between the 2 feeder rollers 325. These components areaffixed to a rigid housing 384 (depicted partially on the side viewonly) to maintain their proper positions and orientations. Otherdepicted components of the embolic delivery system 324 include amounting hole 382, and a shaft sleeve 383. Also shown is an introducercatheter 200 and embolic agent 1, shown being advanced into an aneurysm582.

The operator (not shown) may manually turn the hand crank 335, which isrigidly and non-movably attached to the drive shaft 332, which is alsorigidly and non-movably attached to the drive pulley 331. The driveshaft 332 is attached to the housing (not shown) to allow rotationalmotion without substantial motion in any other dimension. Rotation ofthe hand crank 335 thus imparts rotational motion to the drive pulley331 as shown by the dashed arrow, which then drives the timing belt 328as shown by solid arrows. The timing belt 328 then drives the timingpulleys 379 in rotational motion (depicted by solid arrows). The timingpulleys 379 are rigidly and non-movably attached to their pulley shafts336 and thus cause the pulley shafts 336 to rotate. They do not move inany other dimension because they are mounted to the wall 372 of thehousing 384 as described above for the drive shaft 332. The feederrollers 325 are rigidly and non-movably attached to the pulley shafts336, so they will rotate along with the timing pulleys 379.

The feeder rollers 325 roughly resemble rigid discs of hard plastic ormetal, however the outer rims may be composed of a softer material witha high coefficient of friction such as a synthetic rubber or urethane toprovide traction against the embolic agent 1 which is sandwiched betweenthe two of them. When pressed against the embolic agent 1 in the mannershown, their rotations will project the embolic agent 1 forward into theintroducer catheter 200 as indicated by the straight solid arrow.Reversal of direction of drive shaft 332 rotation will cause theopposite motion of the embolic agent 1, withdrawing it from theintroducer catheter 200.

The tensioner pulley 343 is also part of the drive train, however it ismounted differently to the housing in order to serve its functions ofproviding proper tension to the timing belt, as well as to re-direct thecourse of the timing belt 328 to perform needed functions such as toprovide to more surface contact area of the timing belt 328 with thetiming pulley 379 seen on the right. A shaft sleeve 383 is mountedslidably in the long mounting hole 382 in the housing (not shown), whichin this example has a simple rectangular shape. When conventional meansof fastening the shaft sleeve 383 to the housing (not shown) are freed,the shaft sleeve 383 may slide up or down within this mounting hole 382.When conventional fastening means are tightened, rigidly securing theshaft sleeve 383 to a specific location in the mounting hole 382, thenit may not move in any dimension relative to the housing. The pulleyshaft 336 may rotate freely within the shaft sleeve 383, but not move inany other dimension once the shaft sleeve 383 is rigidly secured withinthe mounting hole 382. The tensioner pulley 343 may be mounted on thepulley shaft 336 either rigidly and non-movably, or in a manner thatallows rotational or translational motion on the pulley shaft 336, sincetensioner pulley 343 is idle and passive and need only rotate freely ina spatial position that permits the application of appropriate tensionon the timing belt 328 for smooth function and proper orientation.

An introducer catheter 200 is shown receiving the embolic agent 1 fromthe feeders in this example. In one embodiment, the embolic agent 1could be fed directly into a specialized element that subsequently leadsit to an introducer catheter 200, or it could be fed into a side portadaptor and/or introducer element 337, as described in FIGS. 16D-Gbefore passing on to an introducer catheter 200. Also in variation, thefeeder rollers 325, and part or all of the remaining elements of theembolic delivery system 324 in FIG. 16A could be enclosed in a housingthat is fluid-tight and capable of being continuously flushed with anirrigant fluid as described elsewhere herein. In one embodiment, insteadof the operator's hand, a conventional power motor, such as a smallelectrical motor, with gearing to produce desired rotational speed couldbe used to power the embolic delivery system 324. In variation, thetensioner pulley 343 mounting apparatus may be less rigidly securedwithin the mounting hole 382 during use, utilizing a spring mechanism orother conventional system that will provide the appropriate tension tothe timing belt 328. The two feeder rollers 325 in FIG. 16A, andassociated timing pulleys 379, are depicted as having their pulleyshafts 336 mounted to the housing 384 with a fixed distance betweenthem. In a variation, at least one of them would be slidably adjustablefrom side to side to give control over the force with which theycompress the embolic agent 1 to provide the optimize the task of pushingit as described herein. A grooved variation of feeder roller 325 is seenin FIG. 16G.

FIG. 16B is a depiction of an embodiment of an embolic delivery system324 similar to FIG. 16A, but with an increase of the surface contactbetween the embolic agent 1 and the elements that push it, through theuse of 2 additional continuous timing belts which also function tofrictionally push the embolic agent 1 and are called feeder belts 378.Many of its components are the same as in FIG. 16A, so for brevity theyare not described here again. In this embodiment, there are six feederpulleys 380 and two timing pulleys 379, which are attached to shafts 336and a housing as described for the feeder rollers 325 and timing pulleys379 in FIG. 16A. A first and second feeder belt 378 pass around thefeeder pulleys 380 in each column. The feeder belts 378 are toothed onthe inside to mesh with the toothed pulleys, but not on the outsidewhere they interface with the embolic agent 1. As the bottom two timingpulleys 379 and associated feeder pulleys 380 are driven by the drivetrain as described in FIG. 16A, they in turn drive first and secondfeeder belts 378, which cause rotation of each feeder pulley 380. Theoutside of these first and second feeder belts 378 is a high frictionmaterial that contacts the embolic agent 1 over substantial length, andits friction against the embolic agent 1 is also aided by the tension ofthe feeder pulleys 380 at each point of pairing of the columns, wheretension may be adjusted to provide optimum propulsion of the embolicagent 1 and smooth function of the system. Embolic agent is shown beingadvanced into introducer catheter 200.

All of the various embodiments described for FIG. 16A could likewise beapplied to those shown in FIG. 16B. Additional embodiments for thatshown in FIG. 16B could include alterations in the outside surface ofthe first and second feeder belts 378. The outside surface of thesefeeder belts 378 could have traction elements of many different types asdescribed elsewhere in this invention, to provide traction against theembolic agent 1 that they contact. Likewise, the embolic agent 1 couldemploy the proper corresponding traction elements as described in thisinvention. The feeder belt 378 could also have a groove runninglongitudinally along the mid portion of its outer surface, somewhat likethe groove 387 described on the feeder roller 325 in FIG. 16G.

FIG. 16C describes another variation of embolic delivery system 324 witha modification that may make it slightly simpler to manufacture, as wellas to reduce the critical distance between the friction surface betweenembolic delivery system 324 elements and the embolic agent 1, which willbe called the free distance 386. The free distance 386 is so namedbecause the embolic agent 1 is “free” from constraint within the feederelements, or the introducer catheter 200 or other component thatreceives the embolic agent 1 from the embolic delivery system 324. Theembolic agent 1 within the free distance 386 is prone to buckling anderrant feeding elsewhere than the introducer catheter 200, resulting infailure, particularly for the more flexible types of embolic agent 1.Reduction of the free distance 386 will therefore help prevent failuresand allow use of more flexible embolic agents 1. In this figure, thefree distance 386 is reduced by using very small diameters of the feederpulleys 380 on their pulley shafts 336 closest to the introducercatheter 200. This allows the proximal end 206 of the introducercatheter 200, which in this example is mildly flared to accept theembolic agent 1, to be very close to the last point of contact with thefeeder belt 378 that is pushing it forward.

The two large feeder pulleys 380 are driven by a drive train (not shown)and could be of the same conventional type as already described in FIGS.16A-B, where a drive pulley drives a timing belt that drives the shaftthat holds the two other elements so they rotate in unison. The twofeeder pulleys 380 in FIG. 16C will rotate in the directions shown bythe curved arrows, thus driving their respective feeder belts 378, whichpass around six small feeder pulleys 380 that are mounted to the housing(not shown) by their pulley shafts 336 so as to permit free rotationaround their longitudinal center-line without any other motion exceptpossibly for some minimal translational motion to permit adjustment ofthe degree of pressure that they apply to each opposing shaft 333 andthus to the embolic agent 1 between them. The feeder belts 378 aretoothed internally to mesh with the pulleys, but have a smooth outersurface to then push the embolic agent 1 forward into the introducercatheter 200 as shown by the straight arrow. As in other variations, thesystem may be operated in reverse to retract the embolic agent 1, and itmay be powered manually or by a power motor.

FIGS. 16D-G include schematic views showing different embodiments ofintroducer elements 337 to facilitate the pushing of the embolic agent 1without buckling or mis-feeding in the free distance 386. FIG. 16D showsa hub 354 of the introducer element 337 where the hub 354 is not flaredor fashioned with any specialized aspects; it is a simple tube shapewith the thinnest possible wall that provides adequate support. Hub 354may be made of metal or strong hard plastic to provide a thin wall. Thismay allow a very low free distance 386. FIG. 16E shows a flared orconical hub 354 that is round in cross section. It increases the capturewidth of embolic agent 1 as described above, but also increases freedistance 386. FIG. 16F includes a side view as well as an overhead viewshowing a more complex hub 354 which includes 2 hoods 446 that extendover the flat planar surfaces of the feeder rollers 325 but do not touchthem. These serve to permit both desirable functions of low freedistance 386 since the non-hooded portions are narrow and can fitbetween the upper portions of the feeder rollers 325, and to also helpto re-direct embolic agent 1 that has strayed out of the plane parallelto the flat plane of the feeder rollers 325. FIG. 16G shows a groovedfeeding roller 325 depicting the groove 387 where the embolic agent 1could be running. This serves to increase the surface area contactbetween the feeder roller 325 and the embolic agent 1, to provide bettertraction, and also to maintain the position of the embolic agent in theprecisely desired spatial location in order to facilitate the pushing ofit into the receiving lumen of the introducer element with less risk ofit buckling or mis-feeding due to angulation of its trajectory.Integration of feeding elements of the embolic delivery system andintroducer elements 337 with other elements in the chain of delivery ofembolic agent to tissue are further outlined in FIGS. 27A-B.

FIG. 17 depicts another novel embolic delivery system 324 forintroduction of a wide variety of embolic agents 1 described herein.Some of the prominent features of this system include a long surfacearea of contact between the driving elements of the embolic deliverysystem 324 and the embolic agent 1 enabling substantial friction betweenthem to facilitate the purpose, as well as a continually constrainingchannel for the passage of the embolic agent 1 through the embolicdelivery system 324 to prevent buckling or kinking of the embolic agent1 at any point before it is deployed within the target tissues beyondthe tip of the introducer catheter (not shown).

The depicted embolic delivery system 324 includes a housing 384 composedof a rigid wall 372 containing a hollow lumen 371 with a complexarchitecture as shown. The lumen 371 is continuous throughout the systemsuch that a fluid injected at inlet port 345 would eventually flow outof the outlet port 346, and could bathe the components at any locationin the lumen 371. The wall 372 could be any rigid material, most likelyplastic or polymer. In this housing are mounted other components thatdrive the embolic agent 1 upward as indicated by dashed arrow. Theseinclude a feeder belt 378 and feeder pulleys 380. Also present, outsidethe housing 384, are connected drive train components including timingpulleys 379, tensioner pulley 343, timing belt 328, pulley shafts 336,drive pulley 331, and drive shaft 332. These drive and feeder elementsare conventionally available. The drive shaft 332 is rotated by anexternal force, which could be manually driven, such as via a hand crankor motor driven as described herein, using conventional mechanicallinkages and gearing as needed. The drive pulley 331 is fixed rigidly tothe drive shaft 332, thus rotating with the drive shaft 332, and causingthe timing belt 328 to move as shown. The timing belt 328 drives thetiming pulleys 379 as shown, with said pulleys rigidly fixed to thepulley shafts 336 which are also rigidly fixed to the feeder pulleys380, which are thus also driven as shown in the top drawing. The pulleyshafts 336 of the timing pulleys 379 pass through substantiallywater-tight holes in the housing 384 to connect to and drive theinternal feeder pulleys 380. The drive shaft 332 and pulley shaft 336 ofthe tensioner pulley 343 do not need to fully penetrate the wall 372 ofthe housing 384. The tensioner pulley 343 serves to route the timingbelt 328 as desired and to maintain proper tension on the timing belt328. The feeder pulleys 380 then drive the feeder belt 378, which ispressed against the embolic agent 1 by the array of smaller feederpulleys 380, and feeds it in the direction as indicated by dashed arrow.

This described embolic delivery system 324 may be connected to anintroducer catheter (not shown) directly or indirectly using meansdescribed elsewhere herein, with transfer of embolic agent from depictedembolic delivery system 324 to remaining portions of invention asdepicted elsewhere herein. The introducer catheter or intermediateelement may be attached to the outlet port 346 using conventionalattachment means. The embolic agent 1 enters the embolic delivery system324 through the inlet port 345, where a side port adaptor (not shown)could also be used to allow passage of embolic agent 1 as well asinfusion of flush solution. In one embodiment, the device may be moreopen, such that the wall 372 does not enclose the lumen 371. In thissystem, fluid flush would not be circulated in the depicted system,although it would usually be used for the side port adaptors andintroducer catheters as described elsewhere herein. In anotherembodiment, many elements of the drive train that are herein depictedoutside of the housing 384 could be located inside the housing, withprotrusion of only the drive shaft.

FIGS. 18A-H depict different embodiments of traction elements 270 thatmay be applied along the inside and/or outside walls of embolic agents 1or modified pusher elements 90, differing from conventional pusherelements as described herein. These traction elements 270 will provideextra friction or mechanical traction when desired for the movement ofthe embolic agent 1 in the desired direction by another element such asa feeder roller in an embolic delivery system or a pusher element 90. Inbrief summation, conventional pusher elements typically push an embolicagent through an introducer catheter whose lumen diameter is verysimilar to the outer diameters of the embolic agent and pusher element,like one piston pushing another through a tube. The devices depicted inFIGS. 18A-F depict novel attributes termed herein as traction elements270 which may provide at least two novel functions, including theability to effect a net forward advancement of the embolic agent 1 byimparting a to-and-fro motion on the pusher element 90 (i.e., conversionof bidirectional motion of the pusher element 90 into unidirectionalmotion of the embolic agent 1 due to a directional bias of the tractionelements) and the retraction of the embolic agent 1 effected byretraction of the pusher element 90 without a rigid attachment betweenthe two elements. The quality of directional bias is present in many butnot all of the traction elements 270 described herein. Even when partialmotion of the embolic agent 1 in the undesired direction occurs, theoverall net effect will be of forward motion of embolic agent 1 despiteto-and-fro motion of the pusher element 90. In other contemplatedembodiments, the pusher element 90 and embolic agent 1 are actuallymechanically locked together when constrained within the introducercatheter 200 however using a different mechanism than as previouslydescribed for FIGS. 1D-1L and 8A-11C. Another function of the tractionelements 270 in some variations may be to simply increase tractionbetween pusher element 90 and embolic agent 1 in systems where theyexist side-by-side within the introducer catheter 200 instead of simplyend-to-end as described in FIG. 1D.

FIGS. 18A-F depict various embolic agents 1, most with traction elements270 as shown. Depicted embolic agents 1 are flexible, composed ofpolymer, but could be composed of any predominantly non-metallicflexible substance such as those listed elsewhere herein. A pusherelement 90 of appropriate length and diameter that would be insertedinto the lumen of the embolic agent 1 would encounter the tractionelements 270, causing traction between the two components so thatmovement of one component may move the other. Such traction may bepreferentially unidirectional, or bidirectional, depending on the natureof the traction elements 270 as described in more detail below.Uni-directional traction could have the effect of net forward motion ofthe embolic agent 1 despite the pusher element 90 having aback-and-forth motion. FIG. 18A depicts an embolic agent 1, hollow,round in cross section, with a lumen 7, a wall 2, and with a full wall 2thickness longitudinal slit 17 running the entire length of the embolicagent 1. It has smooth inner and outer surfaces with a proximal end 17,a middle 20, and a distal end 19. FIG. 18B depicts the embolic agent 1,opened up along the longitudinal slit 17 to expose the inner surface,which can be seen to be smooth. Such a splaying open defies the memoryof the embolic agent 1, which would appear as FIG. 18A in its restingstate, however is opened in FIG. 18B for purposes of description.Traction element 270 in the form of an adhesive compound 50 is appliedto the surface. This compound could be of many types of glues orcements, but would preferably be biocompatible, not having harmfuleffects if small amounts remained on the embolic agent 1 afterdeployment, and also would provide only a weak bond that is sufficientto provide the necessary traction, but weak enough to permit easyseparation of the embolic agent 1 from the pusher element 90 whendesired. This would allow for bidirectional traction. Similarly, FIGS.18C-F are similar views of similar embolic agents 1 except with tractionelements 270 integrated along their internal surface. FIG. 18C depictstraction elements 270 of roughness 271 distributed along the entireinner surface. This roughness could result from scoring of the surfacewith a sharp blade, or special cutting tool that produces a scoringpattern, or from molding of the surface during manufacture. Chemicaltreatment could also potentially result in a rough texture. Suchroughness may cause increased traction in a bidirectional manner uponmotion of an appropriate pusher element 90, such as one with smoothouter surface as seen in FIG. 18I. If the pusher element 90 haddirectional traction elements 270 on its outer surface as describedbelow for FIG. 18M, the traction of the two components when usedtogether could now be preferentially unidirectional.

FIG. 18D depicts an embolic agent 1 with traction elements 270 composedof small ridges 272. These mildly elevated ridges 272 are showncircumferentially around the inner surface, although in variation theycould be less than circumferential. They are shown as symmetrical alongtheir long axis, so as to provide bi-directional traction when used inconjunction with a non-directional pusher element 90 such as that seenin FIG. 18I. Preferentially unidirectional traction could occur if usedwith a pusher element 90 with unidirectional traction elements 270 suchas depicted in FIG. 18M. In a variation, these ridges 272 may beasymmetrical along the long axis of the embolic agent 1 so as to provideunidirectional traction even when used with a bidirectional pusherelement 90 such as in FIG. 18I. Ridges 272 may be formed by the cuttingaway of material around them during manufacture, or by the building upof the ridges by application of material that is welded or cemented tothe surface.

FIG. 18E depicts an embolic agent 1 with traction elements 270 in theform of barbs 273 directed downward, applied to the inner surface. Barbs273 may be applied to the surface with cement, or created by extractionof material from the wall of the catheter around them. They providepreferential unidirectional traction when used with any type of pusherelement 90. FIG. 18F depicts an embolic agent 1 with the tractionelements 270 scales 274, similar to fish scales, directed downward onthe surface. These will also exert preferentially unilateral traction.FIG. 18G-H are contemplated embodiments showing variation of scales 274,with a circumferential scale 274 pattern around the lumen 7 in FIG. 18G,and non-circumferential scales 274 around the lumen 7 in FIG. 18H.

FIGS. 18I-M depict variations of surface properties and tractionelements 270 on the surfaces of various examples of pusher elements 90.FIG. 18I depicts a smooth surface on a standard pusher element 90 withadded traction elements 270 of adhesive 50. It has a proximal end 91, amiddle 93, and a distal end 92. FIGS. 18J-M depict pusher elements 90with added traction elements 270, and a transition 95 between surfacewith transition elements 270 and surface with no traction elements 270.The traction elements include roughness 271 in FIG. 18J, ridges 272 inFIG. 18K, barbs 273 in FIG. 18L, and scales 274 in FIG. 18M, where theyare depicted in two examples of configurations, includingcircumferential and non-circumferential. The direction of thedirectional traction elements 270 in FIGS. 18L-M are reversed from thedirection of the traction elements 270 on the embolic agents 1 in FIGS.18E-H because the usual intention in practice would be to advance theembolic agent 1 upon advancement of the pusher element 90.

Any of the pusher elements 90 depicted in FIGS. 18I-M could be used incombination with any of the embolic agents 1 in FIGS. 18A-18F, fordifferent effects. Variations in the devices in FIGS. 18A-M couldinclude many factors including longer or shorter lengths than thoseshown (in practice the pusher elements 90 would likely be considerablylonger), absence of a transition 95 with traction elements 270 alongentire length, and other possible types of irregularities or non-smoothtextures to provide traction, both in a uni-directional orbi-directional manner. Any of the circumferential traction elements 270could be non-circumferential. The embolic agents 1 may not contain alongitudinal slit 17 or slit 17 may be incomplete or spiral inconfiguration. Instead of ridges added to the surface, depressions inthe surface could be cut away to provide traction and a similar surfaceeffect. In variations, the described traction elements 270 may occupyonly portions of the inner surface. The traction elements 270 may alsobe applied to the outer surface of the embolic agents 1, alone or incombination with application to inner surface. The method of usingembolic agents 1 or pusher elements 90 with traction elements isdescribed in more detail in discussion of embolic delivery systems.

FIGS. 19A-E show other types of traction elements 270, which differmainly from those in FIGS. 18A-18M in that the pusher element 90 andembolic agent 1 are adjacent within the lumen 209 of the introducercatheter 200 during the method of use to be described. In these figures,the introducer catheter 200 is seen to have a wall 208 and lumen 209 asin other depictions. In the lumen 209 are an embolic agent 1, and apusher element 90, side by side.

In FIG. 19A, a simple configuration is depicted where the introducercatheter 200 and pusher element 90 are both round in cross-section, asin usual conventional elements known commonly in the art. This provideslittle traction between them since there is little surface area contact,so movement of one of them may not effect significant motion of theother. FIG. 19B depicts a configuration for embolic agent 1 and pusherelement 90 whereby there is an increase in the surface area of contactbetween the two elements, thus leading to more traction so that motionof the pusher element 90 along its longitudinal axis is more likely toresult in similar motion of the embolic agent 1. FIGS. 19C, 19D, and 19Eshow different configurations of traction elements to increase frictionbetween them while maintaining a round cross sectional shape for the twoof them together as shown. The traction between the elements depends onfrictional forces since the depicted configurations do not lead to amechanical locking together of them with respect to motion along thelongitudinal axis. The traction elements do not need to deform toprevent sliding of one element against the other while constrainedwithin the introducer 200. The function of the traction elements 270seen in FIGS. 19A-E can be many fold and will also be described indescriptions of embolic delivery systems herein. One way to make use ofthese elements could be for the operator to pinch the embolic agent 1and pusher element 90 together with his fingers outside of the proximalhub of the introducer catheter 200, and then advance them as a unit.This could be useful if the embolic agent 1 were so flexible (tofacilitate nesting within the target tissues) that it is difficult toadvance through the catheter alone. Once the pusher element 90 reachedthe target tissues, the embolic agent 1 could be held stationary whilethe pusher element 90 was withdrawn until the tip was near the proximalhub of the introducer catheter 200, when the cycle could be repeated andthe 2 elements could be pinched together and advanced as a unit again.This could result in a rapid administration of a large amount, or greatlength, of embolic agent 1 as the pusher element 90 could be advancedand withdrawn repeatedly fairly rapidly since it may never completely beretracted out of the catheter. This method could also be automated,whereby a machine performs the same simple manipulations just describedfor the operator's hands. This is shown in more detail in discussion ofan embolic delivery system elsewhere herein.

FIGS. 20A-20H depict traction elements 270 having additional mechanicallocking functionality beyond simple friction. These traction elements270 prevent sliding of the embolic agent 1 along the pusher element 90while constrained within the catheter, unless there is deformation ofone of the elements. Thus prevention of sliding is not due to frictionalone as was described for FIGS. 19A-E. There configurations enable 1:1forward (advancement) or backward (retraction) motion of the embolicagent 1 by manipulation of the pusher element 90 with little or nosliding between them, however they do not permit unidirectional bias ofmotion, so a bidirectional motion of the pusher element 90 cannot beused to effect a net forward motion of the embolic agent 1, differingfrom FIGS. 19A-E. FIG. 20A depicts a locking traction element 270. Theembolic agent 1 is engaged with the pusher element 90 when inside thelumen of an introducer catheter 200 (not shown). Both embolic agent 1and pusher element 90 have traction elements 270 with depressions 280and protuberances 279 that mate together. Both elements are roughlyround in cross-section, whereas in FIG. 20B the cross-sectional shape ofthe embolic agent 1 and pusher element 90 are both closed incompletecircles so that when mated, they are together round in cross section, tobetter conform to the lumen 209 of the introducer catheter 200. In FIG.20C, as the elements of FIG. 20B are pushed out of the tip 211 of theintroducer catheter 200, as indicated by the arrow, they are no longerconstrained, and may separate.

Two other types of locking mechanical traction element 270configurations are depicted in FIGS. 20D-F and FIG. 20G-H. FIGS. 20D-Edepict traction elements 270 comprised of pins 277 on the pusher element90 and holes 278 on the embolic agent 1 that fit together when they areconstrained together inside the catheter lumen. FIGS. 20F-H depict anembolic agent 1 and pusher element 90 that have traction elements 270comprised of depressions 280 and protuberances 279 that mate as seen inFIG. 20G. In FIG. 20H, it can be seen that the overall cross-sectionalshape of the conglomerate is roughly round, thus fitting into a roundlumen of an introducer catheter 200. These traction elements 270 mayhave advantage in manufacturing, as the depressions 280 andprotuberances 279 could be created by a rotating round tool or file thatis applied to the embolic agent 1 and pusher element 90.

FIG. 21A disclose one embodiment where the pusher element 90 may be of asimpler manufacture than a similar variation shown in FIG. 20D-E. InFIG. 21A, the embolic agent 1 has many traction elements 270 in the formof pins 277 along the otherwise flat face of its length in two columnsas shown. As in FIG. 20D, embolic agent 1 cross sectional shape is aclosed incomplete circle (where the pins 277 are not located). Thepusher element 90, unlike FIG. 20D, does not have corresponding holes,and instead is a deformable member with enough tensile strength toresist substantial stretching or breaking when pulled with enough forceto cause motion of the embolic agent 1. It is also semi-rigid as inother described pusher elements 90 described herein. Its traction withthe embolic agent 1 is derived from the tendency for the pins 277 of theembolic agent 1 to press into, and deform, the mating surface of thepusher element 90 when both are constrained inside the introducercatheter 200. The cross-sectional view on top right depicts the embolicelement 1 and the pusher elements 90 in their natural state outside ofan introducer catheter 200. Note that the pusher element 90 in crosssection is basically a rectangle with rounded corners as shown, althoughin variation it may not have rounded corners, or may be a closedincomplete circle as in FIG. 20D. FIG. 21A also shows the deformedconfiguration of the pusher element 90 in the cross sectional view onthe lower right, where it is constrained inside the lumen 209 of theintroducer catheter 200 with the embolic agent 1. The depressions 280 inthe deformable pusher element 90 caused by the pins 277 of the embolicagent 1 serve to provide traction between the embolic agent 1 and thepusher element 90 so that pushing or pulling the pusher element 90 willcause corresponding motion of the embolic agent 1. In variation, thepins 277 could be on the pusher element 90, while the embolic agent 1could be the deformable agent without pins 277 or corresponding holes.This may offer advantage in some situations where it is more desirablefor purposes of manufacture, or purposes of functional properties, tomake the embolic agent 1 more deformable, and place the more rigidtraction elements 270 such as the pins 277 on the pusher element 90.

FIG. 21B is a longitudinal and cross sectional view of another variationwhere the traction elements 270 consist of barbs 273 on the embolicagent 1, and the deformable pusher element 90 has traction against theembolic agent 1 when constrained in the introducer catheter 200 asshown. They are shown being pushed or pulled out of the lumen 209 of theintroducer catheter 200. The pusher element 90 could be composed ofdifferent materials, including soft plastic or polymer, or a woven stripas will be described FIG. 21C. In variation, the traction elements 270could be scales 274 or one of the many other traction elements 270described herein. Also, the traction elements 270 could be on the pusherelement 90 instead of the embolic agent 1, and the deformable agentwould be the embolic agent 1.

FIG. 21C is a perspective view of a small magnified portion of a wovenstrip serving as a pusher element 90 as seen more grossly in FIG. 21A orFIG. 21B. The micro filaments 106 are woven, as shown in FIG. 21C, intoa strip that can be extremely long (shown here truncated at the top andbottom). The longitudinal fibers give the strip a high tensile strength,and the horizontal weave gives it a definable shape, as well asproviding a means for traction elements 270 such as barbs 273 on theembolic agent 1 (not shown) to catch on and provide traction, since theywould typically hook over these horizontal fibers because they would beoriented as in FIG. 21B, and the strip would be moving along itslongitudinal axis as it is pulled or pushed. This pusher element 90could be of many different shapes in its cross section, from a simpleround shape, to a rounded rectangle, or other shape that suited thepurpose of the specific embolic delivery system 324 or introducercatheter 200.

FIG. 21D depicts a system which provides traction of pusher element 90against embolic agent 1 while permitting a circular cross-sectionalshape of embolic agent 1 for ease of manufacture and passage throughconventional elements. Pusher element 90 and introducer catheter 200with an embolic agent 1 seen in perspective view, embolic agent 1 andpusher element 90 outside of a catheter and constrained within the lumen209 of an introducer catheter 200, which has a wall 208. In the depictedembodiment, the embolic agent 1 is a helical wire 33 with central wire 6as described herein. The pusher element 90 is a solid member composed ofmaterial, such as solid polymer or woven substance, as depicted in FIG.21C, which is flexible to lateral bending, but has substantial tensilestrength like a typical household string. When constrained in theintroducer catheter 200, it deforms somewhat to increase surface contactarea with the embolic agent 1 and corresponding ridges 272 of the wovenwire, which are serving also as traction elements 270. Pushing orpulling the pusher element 90 will therefore move the embolic agent 1correspondingly. This type of system may be useful in a variation of theembolic delivery system 324 such as seen in FIGS. 22B and 22G. It hasthe feature of stabilization of the embolic agent 1 to lateral movementwhile in the embolic delivery system 324, because the diameter of theembolic agent 1 is greater than the width of the lumen 209 containingthe pusher element 90, so the non-compressible embolic agent 1 cannotpass into the smaller portion of the lumen 209 once the pusher element90 has been stripped away, in a system similar to FIG. 22B or 22G wherethe embolic agent 1 passes into a smaller lumen which is a circle incross-section and only slightly larger than the diameter of the embolicagent 1.

FIG. 21E is a depiction of another variation of traction elements 270used with embolic agent 1 and pusher element 90, where both areresistant to axial compression and therefore maintain circularconfiguration in cross section even when pushed together side-by-side aswhen constrained within the lumen 209 of an introducer catheter 200(seen in cross section view only) which has a wall 208 that resistsaxial stretching or change in shape. Both have scales 274, which areoriented in opposite directions as shown, to provide traction. Invariation, many other types of traction elements 270, as describedherein, may be used with similar effect.

FIG. 21F depicts a manufacturing element 630 that may assist in themanufacture of the type of embolic agent 1 shown in FIG. 21D. Itconsists of a very rigid press 631 through which the embolic agent 1 andthe pusher element 90 may be positioned as shown. Embolic agent 1 hastraction elements 270 consisting of ridges 272. External force indirection indicated by large arrows may be applied, which allows thepress to be compacted via the press joints 632 where the two componentsare slidably connected. This results in compression of the pusherelement 90 against the embolic agent 1 with great force, causing them tobond together in a detachable manner that permits their function asdescribed in this invention. If the mechanical attachment caused by theimpression and deformity of the deformable pusher element against theridges 272 on the embolic agent 1 did not provide sufficient bondingforce, then it could be aided with addition of a sticky substance ofadhesive so long as bonding was not so excessive as to prohibitdissociation during usage.

FIGS. 22A-G depict a system and variations that have a novel method ofcausing advancement of the embolic agent 1 by pulling a very flexiblepusher element 90 which is adjacent to the embolic agent 1 and exertsforce on it using traction elements 270, and which is then stripped awayfrom embolic agent 1 which continues to be projected forward. Theserepresent another novel system and method for delivery of embolic agent1 into abnormal tissues. FIG. 22A is an upper perspective view ofexamples of pusher element 90, traction elements 270, and embolic agent1. The traction elements 270 in this example are convex on embolic agent1 and concave on pusher element 90 versions of the same pattern, wherethe contour is a series of repeating depressions 280 and protuberances279 that can nest together without increasing the overall diameter ofthe larger member, in this case the embolic agent 1. The pusher element90 is inserted into the concavity of the embolic agent 1, where itnests, with traction elements 270 on both members engaged. When nested,the overall configuration in cross-section is roughly circular, as seenlater in FIG. 22B. It is evident in FIG. 22B that a pulling or pushingmotion of the pusher element 90 would cause a similar motion of theembolic agent 1, especially if they were both in the restrictive lumen371 of embolic delivery system 324. FIG. 22B depicts views of theembolic agent 1 and pusher element 90 and traction elements 270 of FIG.22A, shown being used with an embolic delivery system 324. The embolicdelivery system 324 has a lumen 371 allowing the passage of an embolicagent 1 from its proximal end 385, through the middle 388, and exitingthe distal end 389, as shown by the arrow. The embolic delivery system324 has a rigid wall 372 for support and to contain fluids and provide afluid-tight seal where needed. The pusher element 90 is fed through abifurcation 375 of the lumen 371 and exits the embolic delivery system324 through a side port 347 as shown by the dotted arrow. The embolicagent 1 enters the embolic delivery system 324 through the inlet port345 and exits through its distal end 389, where it may then pass intointroducer catheter (not shown) or other intermediate elements asdescribed herein. Many variations of traction elements 270 are possiblewith similar effects. The driving force for the advancement of theembolic agent 1 comes from the pusher element 90, which may be pulled bythe operator's hands, or by more components of the embolic deliverysystem 324, as shown in this depiction, where the pusher element 90 isbeing pulled by a spool 364 with a hand crank 335, the latter twoelements being depicted in a drawing of different scale in FIG. 22Cwhere the spool 364 and hand crank 335 are shown in overhead and sideviews, and the pusher element 90 is also seen rolled up on the spool364. In FIGS. 22B and 22C, the operator turns the hand crank 335, whichis attached to the spool 364, and thereby the spool turns, taking up thepusher element 90, and thereby pulling it from the from embolic deliverydevice 324, thereby causing the described motions of the pusher element90 and embolic agent 1. The spool 364 permits rapid deployment, andcontainment of the length of used pusher element 90, which, fortreatment of a large abnormal cavity, could possibly be several hundredfeet in length. These bulky components such as the spool 364 oroperator's hands, providing the driving force for the pusher element 90would be outside of the body that contains the abnormal cavity to betreated, while the distal end of the introducer catheter (not shown) isinside the body. Thus the small diameter elements are inside the body,while the larger elements do not require insertion through body tissues.Once the desired length of embolic agent 1 has been delivered, ordetermined, methods for completion including severing of the embolicagent 1, or placement of short segments, or pushing of the last portionwith a conventional pusher element 90 that is simply pushed by theoperators hand and thrusts the trailing end of the embolic agent 1forward, may be used, and these techniques are described in more detailelsewhere herein for different embodiments of the invention.

FIG. 22D depicts a minor variation where the side port 347 has an obtuseangle of departure from the embolic delivery system 324. This mightserve to reduce friction and binding forces of the pusher element 90against the lumen 371 of the embolic delivery system 324, facilitatingthe intended function of the system, and reducing risk of breakage ofthe pusher element 90, and to enable a reduction in rigidity orthickness of the proximal end 385 of the embolic delivery system 324since the force of retraction of the pusher element 90 will not bedirected proximally, which potentially bend the embolic delivery system324 if the elements were not rigid enough to prevent it. The forcerequired to pull the pusher element 90 can be provided by similar meansas in FIG. 22B. The embodiments depicted in FIGS. 22A-G have anotheradvantage of permitting the pusher element 90 to be highly flexible,without need for columnar strength, since it is being used as a pullingagent. It will therefore need to have adequate flexibility to roundbends and tensile strength to withstand pulling forces.

FIG. 22E shows two variations of embolic delivery systems 324 todemonstrate possible differences in proportions of devices described inFIGS. 22B, 22D, and 22G. In the example on bottom, the distance from hub354 to bifurcation 375 is quite short, so that only the narrowerdiameter portion of the embolic delivery system 324 would be insertedinto the body thereby reducing the diameter of the opening to a minimum,and serving in a manner similar to an introducer catheter as describedherein. In the top example, the distance from hub 354 to bifurcation 375could be much longer, so that traction on the embolic agent 1 occursclose to the distal end 389 of the embolic delivery system 324, ensuringforward motion of even very flexible and soft embolic agents 1. Such anembodiment might be used in conjunction with a small diameter introducercatheter as described elsewhere, or may be used in a manner similar toan introducer catheter, i.e. partially inserted into the body

In a variation of the foregoing, it is easy to envision the use of manydifferent types of traction elements 270, embolic agents 1, or pusherelements 90 than depicted, with similar effect. By way of some examples,the embolic agent 1 and pusher element 90 may be shaped verydifferently; they could be square or rectangular in cross section, andthey could employ any type of traction element described herein. Theycould use an adhesive bond or electrostatic attraction instead of theother traction elements. There could be very small microfilament ties orbands connecting the two elements, possibly wrapping around theelements, said bands being easily broken when they are pulled apart.There could be stitching of very fine filament that is bound tightly tothe pusher element 90 being stripped away, but is loosely stitchedaround the embolic agent 1 such that gentle traction when desired willunravel the stitching and dis-associate the two elements, leaving thesmall fibers attached to the pusher element 90 which is not implanted.The embolic agent 1 could be nested inside the pusher element 90 insteadof the opposite as depicted in FIG. 22A. Many other variations arepossible that would still be in keeping with the novel aspects of thisinvention.

FIGS. 22F-G depict an embodiment as described and shown in FIGS. 22A-E.FIG. 22F shows an embolic agent 1 that includes traction elements 270composed of ridges 272, which could also be described as an alternatingseries of protuberances 279 and depressions 280 in a pattern often seenin conventional helical wires. The pusher element 90 is seen wrappedaround the embolic agent 1 with a longitudinal slit 96 that makes thecross-sectional configuration an incomplete circle (also shown in FIG.22G.) The outside surface of the pusher element 90 is smooth, but theinner surface has traction elements 270 corresponding to those of theembolic agent 1 to allow a mating of the elements, and also consistingof alternating series of protuberances 279 and depressions 280. Alsoshown in FIG. 22F, the pusher element 90 is seen being stripped awayfrom the embolic agent 1 by a force directed upward and to the right,depicted by the arrow. When this leading edge of the pusher element 90is pulled by the operator or other means, it can forcibly unwrap fromaround the embolic agent 1 that it enveloped, and in doing so, thetraction elements 270 will exert an upward force on the embolic agent 1so long as the embolic agent 1 is forcibly maintained in the sameorientation by an external element such as the lumen 371 of the embolicdelivery system 324 seen in FIG. 22G.

In FIG. 22G, an embodiment of the embolic delivery system is shown.Embolic delivery system 324 with a wall 372, lumens 371, a bifurcation375 of the lumens 371, a side port 347, and an inlet port 345 is shown.The embolic agent 1 and pusher element 90 of FIG. 22F are seen passinginto the inlet port 345 of the embolic delivery system 324, with thepusher element 90 enveloping the embolic agent 1. In this exampleembodiment, the embolic agent 1 is composed of a series of shortersegments 52 that have a proximal end 18 that abuts the distal end 19 ofthe adjacent segment. Before entering the embolic delivery system 324,these segments are maintained in proper position by the continuousenveloping pusher element 90. When these elements reach the bifurcation375 of the lumen 371 into two lumens 371, one of which continuesstraight on and provides a channel for the movement of the embolic agent1 to the target tissues (not shown), and the other lumen 371 bifurcatingat an angle and providing passage for the pusher element 90. The embolicagent 1 is maintained within the larger of the two lumens 371 because itis too large to fit into the smaller one, and because its direction ofmotion in a straight line is maintained by its inability to prolapseinto the smaller lumen 371 during normal forces of normal operation,while the pusher element 90 unwraps from around the embolic agent 1,crumples due to its flexibility and poorly formed shape when notcontaining the cylindrical embolic agent 1, and is pulled by theoperator or other instrument out through the side port 347. The pusherelement 90 is depicted as a dashed line as it passes around the embolicagent 1 near the bifurcation 375 to indicate that is it out of the planeof the 2-dimensional longitudinal section in this figure. The pusherelement 90 will provide an upward force on the embolic agent 1, drivingit forward. Each segment 52 of embolic agent 1 will push the previousone forward, since they are all constrained in a lumen 371 that is onlyslightly larger than the diameter of the embolic agent 1. The use ofsegmented embolic agent 1 is optional, and instead a very long singleelement may be used as described elsewhere herein. As depicted, thissystem performs the novel function of administering numerous short ormedium length embolic agents 1 in rapid succession.

Different methods of manufacture of the pusher element 90 are possible.It could be injection molded, made of polymer, to its desired shape. Itcould be made like a conventional smooth-walled tube, and then the slit96 added to the side, then the traction elements 270 cut or heat-moldedon. It could be made from a heat-shrinkable tubing, possibly reinforcedwith longitudinal fiber elements of high tensile strength, into whichthe embolic agent 1 is inserted, then heat applied, and the pusherelement conforms to the contour of the embolic agent 1 then thelongitudinal slit 96 applied by a cut.

Many variations of the system in FIGS. 22F-G are possible. Almost anytype of traction element 270 could be used instead of those depicted.The surfaces of the embolic agent 1 and pusher element 90 could all besmooth, and the necessary traction supplied by frictional forces, or theapplication of a small amount of weak adhesive that can be overcome whennecessary for the elements to separate. Different shapes of emboliccould be issued instead of cylindrical; it could be dumbbell shaped, orof many different types of shape.

FIG. 22H depicts another variation of embolic delivery system 324variation of the previous two figures, employing the use of embolicagent 1 and pusher element 90 that employs traction elements 270 in amanner that causes forward propulsion of the embolic agent 1 by usingpulling forces instead of simply pushing forces, thus taking advantageof the advantages of the effects of pulling flexible objects overpushing them. This is novel since current mechanisms for advancingembolic agents in conventional systems use pushing forces only. Theembolic delivery system 324 includes a housing 384 with a wall 372 and ahollow lumen 371 that is continuous throughout and allows passage ofother elements as well as infusion of fluids. It also has a side-port347 for conventional delivery of infusion fluids, an inlet port 345 forentrance of the embolic agent 1, and an outlet port 346 for exit of theembolic agent 1. It also has another inlet port 345 for entrance of thepusher element 90, and another outlet port 346 for the exit of thepusher element 90. Embolic agent 1 and pusher element 90 are intended tousually travel in the direction shown by the arrows, although retractionin the opposite direction may occur sometimes for proper position of theembolic in the target tissues (not shown). All of the inlet ports 345,and the outlet port 346 for the pusher element 90 include an O-ring 373to allow adjustable fluid-tight seal around the elements passing throughthem. The outlet port 346 for the embolic agent 1 is a conventionalrotating male connector that may connect and lock to conventional femaleconnections widely used in the art, and which may be on the proximal endof an introducer catheter (not shown) so that the embolic agent 1 may besmoothly and easily transferred from the depicted embolic deliverysystem 324 into the introducer catheter or intermediate element thatleads to introducer catheter that carries the embolic agent 1 to thetarget tissues.

The embolic agent 1 may have traction elements 270 as shown, in thisexample in the form of ridges 272, although many variations arepossible. The embolic agent in this example is a helical wire 33 withcentral wire 6 as described herein, and is flexible to lateral bendingbut semi-rigid to axial compression. The pusher element 90 shown doesnot have traction elements, and is instead softer than the embolic agent1 and will therefore conform to the contour of the ridges 272 as shownin the figure, when the two elements are pressed together by theconstraints of the system, and the pressure caused by the feeder pulleys380. In other embodiments, traction elements 270 may also be on thepusher element 90, or may be only on the pusher element 90 and not onthe embolic agent 1. The feeder pulleys 380 rotate around the pulleyshafts 336 that are fixed to the wall 372 of the housing 384, so theironly allowed motion is rotational. They directly contact the pusherelement 90 and embolic agent 1 and are within the lumen 371 of theembolic delivery system 324. The feeder pulleys 380 squeeze the embolicagent 1 and pusher element 90 together to increase the friction andtraction between them. In variation, more sets of feeder pulleys 380 maybe included for more areas of pressure. The operator (not shown) maypull the pusher element 90 from its upper aspect outside the confines ofthe embolic delivery system 324, causing forward motion of the embolicagent 1 and pusher element 90 as shown by arrows. In another embodiment,the pusher element 90 may be a continuous loop, like a belt, so that itcan be much shorter perform the same function as depicted. This loop maybe manually pulled by the operator, or could be connected to a drivesystem similar to that shown in FIG. 17. The drive system could beoutside of the housing 384 of the embolic delivery system 324. Thisembodiment could also be considered a variation of FIG. 17 where thepusher element 90 essentially becomes very similar to the feeder belt378 in FIG. 17, and the main difference between them is the fewer driveelements inside the lumen 371 in FIG. 22H. To this effect furthervariation could include bilateral and symmetric pusher elements 90 andfeeder pulleys 380 for the system of FIG. 22H. In other variation, theembolic agent 1 and pusher element 90 may be packaged together bymanufacturer, similar to method seen in FIG. 22B, FIG. 22D, and FIG.22G, and enter together through the main inlet port 345 instead ofdepicted example in FIG. 22H where pusher element 90 enters separatelyvia second inlet port 345. Another variation could include a second ormore set of feeder pulleys 380, particularly near the bifurcation 375 toassist with compression of embolic agent 1 against pusher element 90,and to provide a smoother motion of moving elements.

FIGS. 23A-E depict an embodiment of embolic delivery system 324 thattranslates a to-and-fro or bidirectional linear motion of the pusherelement 90 into incremental linear forward motion of the embolic agent1. In brief summary of operation, an upward linear motion of the lineartrolley 410 effects a predominantly and roughly similar linear motion ofthe cam 407 and cam block 408, but also causes a very slight clockwiserotation of the cam 407 causing it to tightly grasp the embolic agent 1and pusher element 90 against the cam block 408, so that linear motionis also imparted to the embolic agent 1 and pusher element 90 in unison.When the direction of linear motion is reversed, the cam 407 rotatescounterclockwise slightly, releasing its grip on the embolic agent 1, sothat the cam 407 and cam block 408 and connected elements may slidepredominantly linearly, without also pulling the embolic agent 1, whichmay remain stationary at this time. The pusher element 90, beingattached to the linear trolley 410 will be retracted. Thus the overalleffect is to advance the embolic agent 1 incrementally with each cycle,while there is no net motion of the pusher element 90 with each cycle.The distal end 92 of the pusher element 90 is depicted close to themiddle 207 of the introducer catheter, however its position within theintroducer catheter 200 is manually adjustable by the operator and couldbe variable as fits the needs of the situation.

FIG. 23A depicts the track portions 406 of a guider 338, both to bedescribed in detail below. It also depicts a magnified 3 dimensionalperspective view of the embolic agent, which is very similar to FIG.18A. The embolic agent 1 has a wall 2 and a central round lumen 7similar to a conventional tube, however with a longitudinal slit 17 offull wall 2 thickness, which in this example extends all the way fromthe distal end 19 to the proximal end 18. FIG. 23A and FIG. 23B bothrepresent the beginning of the motion cycle where all components arestationary for a point in time as one cycle ends and another begins, anddirection of linear motion is reversed as described below. FIGS. 23B-Edepict the system sequentially during a complete cycle. In FIG. 23A, anembolic delivery system 324 contains a guider 338, a rigid cam 407, arigid cam block 408, a simple guider 416 attached to the cam block 408,and a rotary-to-linear motion apparatus which includes several rigidcomponents including a first linkage arm 341, and a second linkage arm393 shown in exploded fashion, a third linkage arm 394, 4 rotationaljoints 342, and upper rotational joint 414 a drive shaft 332, 4 tracks406, and 7 track pins 409, and a simple guider 416. One of the trackpins 409, located on the cam 407, also serves as the upper rotationaljoint 414 of the cam 407.

Function and further detail is now provided for FIGS. 23A-E. The driveshaft 332 is rotated by a drive train that is not pictured here but usesa conventional rotary system such as a hand-crank or electric motor andgearing as needed. The rotating drive shaft 332 is connected rigidly tothe first linkage arm 341, which is connected to the second linkage arm393 by a rotating joint 342 that allows only rotary motion, like a pivotpoint, as is the case for all rotating joints 342 in this figure. Thesecond linkage arm 393 is connected to the linear trolley 410 by arotational joint 342. The linear trolley 410 is slidably connected totwo fixed, stationary tracks 406 via track pins 409 as shown anddetailed further in the cross section view. The track pins 409 arerigidly connected to the linear trolley 410, which rests on the tracks406. The tracks are rigidly incorporated into the rigid board 411 whichserves as the stabilizing mount for several elements including thetracks 406, guider 338, and side port adaptor 530, none of which maymove in any direction relative to the board 411. The rigid board 411 isgenerally flat in this depiction, however may have various contours asneeded to mount components in a conventional manner in order to achievethe effects described herein. The board 411 may be composed of any rigidmaterial or rigid compound such as hard plastic. It serves an importantrole in maintaining the proper alignment of various components for theirfunction as being described herein. Components not directly connected tothe board 411 may be permitted to move more flexibly according to theirspecific characteristics, e.g. the introducer catheter 200 which passesfrom the outside of the body 580 to the inside of the body 580.

The four track pins 409 and the linear trolley 410 may only move in apurely linear fashion along the Y axis by sliding of the track pins 409in the cam block 408. The shape of the track pins 409 and cam block 408do not permit detachment of the two elements or substantial motion inthe X or Z axes. Thus the rotary motion of the drive shaft 332 isconverted to linear motion of the linear trolley 410 by the action ofthe first linkage arm 341 and second linkage arm 393 as will be shown inFIGS. 23B-E. The pusher element 90 is detachably, rigidly connected tothe linear trolley 410 by passing through a hole oriented along the Yaxis of the linear trolley 410 as shown, with a set screw 412 that maybe tightened to secure the pusher element 90 rigidly, or loosened toallow it to slide in the hole 413 in the linear trolley 410. In FIGS.23A-E the set screw 412 is always tight so the pusher element 90 isalways secured. The operator may choose to loosen it for variousfunctions not described in detail herein such as manual operation of thepusher element 90 for many purposes commonly practiced in the art. Thelinear trolley 410 and the cam 407 are connected by the third linkagearm 394 by 2 rotating joints 342 so that the linear motion may besubstantially transferred to the cam 407 and connected componentsincluding the cam block 408, and attached smaller elements to bedescribed. Of important note is that the linear motion of the lineartrolley 410 is not entirely transferred to the cam 407 because themounting system of the cam also permits rotational motion of the cam 407around the upper rotational joint 414 of the cam, which is also thetrack pin 409 for the cam, thus keeping a purely linear motion of thecenter point of the track pin 409 and upper rotational joint 414 whileallowing a swivel or rotational motion of the cam 407 in addition to itslinear motion. The cam 407 is attached to its cam block 408 solely bythis one track pin 409 so that its rotation may occur. Notably, therotational motion of the cam is very minimal, perhaps only a fewdegrees, because upon being rotated clockwise, the cam meets the camblock 408 and the interposed embolic agent 1 containing the pusherelement 90, and may not rotate further because the cam block 408 ismounted to its cam block 408 by two track pins 409 and therefore mayonly move linearly in the Y axis without substantial rotation. Alsoimportant to this relationship is the connection between the cam 407 andcam block 408 is solely at the upper rotational joint 414, thuspermitting rotation motion of the cam but not the cam block. Therotational joint 342 of the cam that connects to the third linkage arm394 does not engage the track, and may thus rotate around the axis ofthe upper rotational joint 414 along with the rest of the cam 407.

Prevention of substantial counterclockwise rotation of the cam 407during an upward linear motion of the system is effected by 2mechanisms, with a third possible mechanism described but not depicted.First, an imaginary dashed line 415 from the center of the rotationaljoint 342 and upper rotational joint 414 of the cam 407 is slightly offthe pure Y axis as shown. This creates a bias towards clockwise rotationof the cam 407 upon upward thrust of the third linkage arm 394. Second,the third linkage arm 394 is also longitudinally oriented slightly offthe Y-axis to create another bias towards clockwise rotation of the cam407 upon upward motion of the third linkage arm 394. Third, aconventional detent mechanism could be mounted on the cam 407 and camblock 408 or other elements in many possible conventional ways toprevent counterclockwise rotation of cam during upward linear motion ofother elements.

Upon downward motion of the linear elements, the reverse rotational cam407 motion will occur. The downward force upon the rotational joint 342of the cam will tend to pull the cam in a counterclockwise directionuntil the described imaginary line 415 is roughly in-line with the longaxis of the third linkage arm 394, which is roughly oriented along the Yaxis with slight bias as described above. Again, the rotational motionof the cam is very small, but is enough to release pressure between thecam 407 and the cam block 408 and therefore free the embolic agent 1 andpusher element 90 from their grasp. The points along the edge of the cam407 facing the cam block 408 have an increasingly greater distance fromthe center of rotation at the upper rotational joint 414 in passing frominferior to superior aspect, in order to provide the gripping functionupon clockwise rotation. This gripping function is enhanced by the cam's407 shape because as commonly occurs with conventional cam grippingmechanisms such as those used in rope climbing gear or other mechanisms,the force in the opposite downward linear direction applied by theembolic agent 1 and pusher element 90 due to some inevitable resistanceto being pushed upward, against the gripping surfaces of the cam 407 andcam block 408 will serve to further force the cam's 407 clockwiserotation. In this manner, the more resistance there is to pushing theembolic agent 1, the greater will be the grasping force around theembolic agent 1 to help increase the friction and push it in the desireddirection. Also to enhance this friction, the cam 407 and cam block 408may be enhanced with material(s) with a high coefficient of frictionsuch as urethane, for example, along the surfaces that come into contactwith the embolic agent 1.

Now the aspects and motion of the embolic agent 1 and the pusher element90 are considered here. As described throughout this invention, anobject is to dispense a potentially large quantity of the embolic agent1 to a relatively large body cavity or target tissue 589, passing itfrom its storage system, through the embolic delivery system 324 andvarious associated components, and through an introducer catheter 200which itself passes from outside of the body 580 to the target tissueinside the body 580. In FIG. 23A, the storage of most of the proximalend 18 of the embolic agent 1 is not depicted, and may be similar to oneof the variations described elsewhere herein. In this example, embolicagent 1 need not be stored inside a tank or enclosed structure, as it isnot necessarily bathed in fluid while in its containment apparatus.Storage in this example could be as simple as a conventional spool orreel, or other method of preventing tangling and providing delivery withlow resistance. Storage of most of the proximal end 91 of the pusherelement 90 is also not depicted. This would usually be accomplished in aconventional manner used commonly in the art, such as simply laying itout in the workspace, either in a straight or curved path, or with oneto three simple coilings performed manually by the operator. The pusherelement's 90 length is not as variable or as great as the embolic agent1 since it is not continuously deployed into the target tissues 589 andis simply a tool of delivery of the embolic agent 1. Therefore it ismanageable using commonly used means in the art.

The course of the embolic agent 1 is discussed now. It is pulled intothe embolic delivery system 324, first entering the guider 338, whoserole it is to prepare the proper position of the embolic agent 1 forfeeding into the mechanism of cam 407 and cam block 408. It also servesto provide a novel function of integrating the flexible hollow embolicagent 1 with the solid semi-rigid pusher element 90 such that the pusherelement 90 is co-axially positioned within the embolic agent 1. Coaxialpositioning of pusher element 90 inside catheters (not embolic agents)is conventional and conventionally accomplished by passing one throughthe end of the other. However, this is not possible in this inventiondue to the great length of the embolic agent 1, so novel aspects includethe entry of the pusher element 90 into the longitudinal slit 17 of theembolic agent 1, as well as the novel use of a hollow embolic agent 1,and the novel method of passing it over the stiffer pusher element 90using coaxial technique. Once the embolic agent 1 exits the guider 338with the pusher element 90 located coaxially inside of it, the embolicagent 1 and pusher element 90 then pass through the simple guider 416which is rigidly attached to the cam block 408. The simple guider 416serves to position the embolic agent 1 and pusher element 90 for feedingin between the cam 407 and cam block 408 as described in more detailshortly. When pushed upwards by the cam 407 and cam block 408, theembolic agent 1 and pusher element 90 then pass into the side-portadaptor 530. Although the side port adaptor 530 is optional and could beeliminated, and the elements fed directly into the introducer catheter200 instead, the side port adaptor 530 may serve to standardize thesystem somewhat since different introducer catheters 200 may be employedwith one standard side port adaptor 530 that could be included with akit. It also permits the application of flushing fluids at this level,which could be infused into the side port 535 using conventional methodsdescribed elsewhere in this invention and standard in the art. Since itslumen 541 becomes continuous with the lumen 209 of the introducercatheter 200 when they are connected rigidly, the flushing fluids maypass into the target tissue 589 in this manner. Once the embolic agent 1and contained pusher element 90 pass though the side port adaptor 530into the introducer catheter 200, and then the embolic agent maycontinue on into the target tissues 589. The pusher element 90 does notsimilarly accumulate in the target tissue 589 due to the mechanismsdescribed in detail herein, and the farthest extent of its distal tipcould be variable and controlled by the operator who may determine whatlength of the element will be distal to the tether point at the setscrew 412. The pusher element will usually not extend beyond the distalend 210 of the introducer catheter 200, or into the target tissue 589,although this may be performed as deemed beneficial by the operator.

Returning now to more details about the guider 338, it is securedrigidly to the board 411 and does not move or have moving parts. Asdepicted in FIG. 23A, the guider 338 has two inlet ports 345 and oneoutlet port 346 all of which are in communication with a central hollowlumen 371. Guider 338 is novel in its design and function, since thelumens 371 of the 2 inlet ports 345 join in a manner that wraps thehollow embolic agent 1 around the pusher element 90. The lumen 371 ofthe inlet port 345 receiving the pusher element 90 is a conventionalhole, round in cross section, as in most conventional catheters andtubes. The lumen of the inlet port 345 for the embolic agent 1 is shownin cross section in the magnified drawing indicated by the dashed lines,and is roughly “C” shaped, within the solid, rigid wall 372, causingsimilar shape for the embolic agent 1. The cross sectional configurationof the inlet port 345 of the guider 338 that accepts the embolic agent 1is therefore suited for receiving the embolic agent in manner wherebythe solid elements of the inlet port 345 are in maximum contact with theinside and outside surfaces of the wall 2 of the embolic agent 1. TheC-shaped wall 2 (in cross section) of the embolic agent 1 fits into theC-shaped lumen 371 of the guider 338. This serves to precisely controlthe position and orientation of the longitudinal slit 17 of the embolicagent 1 for optimum smooth opening and wrapping around the pusherelement 90 that occurs at the bifurcation 375 region of the guider 338.Moving to the cross-sectional drawing of the inlet port 345 for theembolic agent 1 corresponding to a location closer to the bifurcation375 as indicated by the dashed lines, the configuration has changedsomewhat as shown. There has been a transition from the abovedescription to a more open shaped lumen 371, more like a sideways “U”,and the cross-sectional diameter of the wall 372 has increased slightly.This serves to correspondingly open the longitudinal slit 17 of theembolic agent 1 to prepare it for acceptance of the pusher element 90 atthe bifurcation 375. Referring now to the third and uppercross-sectional drawing of the guider 338, corresponding to the level ofthe outlet port 346 where the two lumens 371 of the two inlet ports 345are now joined into one lumen 371 containing the embolic agent 1 whichis wrapped around the pusher element 90. Now the lumen 371 of the guider338 is seen to be round and conventional in cross section.

The pusher element 90 in this depiction is a standard metal wire type,flexible with substantial, providing the columnar strength andresistance to buckling and kinking that facilitate the pushing of itselfand the embolic agent 1 forward through the system elements into thetarget tissue 589, overcoming the resistances along the way. It is wellknown in the art that a highly flexible micro catheter, similar in manyways to the highly flexible embolic agent 1 in this example, is moreeasily advanced through catheters when a stiffer wire is positionedinside its lumen. Such forward motion is enhanced further by thesimultaneous advancement of both elements, facilitating the advancementof the embolic agent 1 which can be quite floppy and difficult toadvance alone.

Inevitably, there will be some undesired friction between the embolicagent 1 and the pusher element 90 within its lumen 7 upon the downwardlinear motion of each cycle when such friction could adversely cause adownward motion of the embolic agent 1. In the depicted invention, thisis prevented by stronger frictional forces on the embolic agent 1 atseveral locations including the body 580, against the internal walls 208of the introducer catheter 200 and side port adaptor 530, against theO-ring 537 of the side port adaptor 530 which may be adjustedaccordingly, against the internal walls 372 of the guider 338, and atthe bifurcation 375 of the guider 338 where a downward force upon theembolic agent 1 would not result in downward motion of the embolic agent1 unless it were strong enough to overcome the forces that would berequired to cause un-wrapping of the embolic agent 1 from the pusherelement 90 and force it downwards through the guider 338. Prevention ofthis unwanted motion could also be facilitated by the use of materialsand/or coatings of the surfaces of the inside wall 2 of the embolicagent 1 and the pusher element 90 so that the frictional forces betweenthem are much less (when not gripped by the cam mechanism) than theopposing forces described above. Thus their synchronous motion wouldonly occur when grasped together by the cam mechanism as describedherein. Further mechanisms for prevention of this unwanted motion arefurther described in FIGS. 23 F-H.

In FIGS. 23B-E the system is depicted at four quarter phases during itscycle. FIG. 23B depicts the phase of the cycle when the linear motionelements are in their maximally retracted (downward) position. At thispoint in time, linear motion is transitioning from downward to upward indirection. The maximum retraction of the third linkage arm 394 isassociated with maximally counterclockwise rotated cam 407 and absenceof grasp of the embolic agent 1 and pusher element 90 by cam 407 and camblock 408. The solid curved arrow depicts the counterclockwise rotationof the drive shaft 332, which is always in this direction.

Progressing to FIG. 23C, the first linkage arm 341 has been rotated intoa horizontal direction as shown, thus lifting and partially rotating thesecond linkage arm 393, thus pushing the linear trolley 410 upwards in apure linear motion through half of its course. This has also pushed thethird linkage arm 394 upward, which at first instant rotates the cam 407slightly clockwise as depicted by the solid curved arrow, and then topush it upward linearly, bringing the cam block 408 upwards linearlywith the cam 407. The pusher element 90 was pushed upward by virtue ofits attachment to the linear trolley 410, as well as due to the grippingforces and motion of the cam mechanism, and its distal end 92 isdepicted closer to the distal end 210 of the introducer catheter 200.The embolic agent 1 was moved upwards by the gripping forces and motionof the cam mechanism, as well as the frictional forces against thepusher element 90, and is seen to be passing further into the targettissue 589.

Progressing to FIG. 23D, the linear motion components are now at theirfull upward extent, and the cam mechanism remains closed, with the cam407 gripped against the embolic agent 1 and cam block 408. The pusherelement 90 is maximally forward in the introducer catheter 200 as seenby its distal end 92 being very close to the distal end 210 of theintroducer catheter 200. The embolic agent 1 has been pushed maximallyinto the target cavity 589 until the cycle repeats.

Progressing to FIG. 23E, the first 341 and second 393 linkage arms areoriented as shown, and the linear motion is now retracted halfwaythrough its downward course. The downward forces caused the cam 407 torotate slightly counterclockwise as shown by solid curved arrow,releasing its grip on the embolic agent 1 which does not movesubstantially during this portion of the cycle when the linear elementsare moving downward. The pusher element 90 is retracted due to its rigidattachment to the linear trolley 410, but does not cause retraction ofthe embolic agent 1 for reasons detailed herein. The cycle repeats whenthe elements reach the position of FIG. 23B in another quarter of acycle.

FIGS. 23F-H depict variations of the above, in part to address thepotential adverse backward slippage of the embolic agent 1 during theportion of the cycle when the linear motion elements are being retracteddownward, as was described in FIG. 23A. A modification of the guider 338may include the addition of a constricting O-ring 537 that is similar tothe O-ring 537 that is part of a conventional side port adaptor 530.This is depicted in FIG. 23F in crude form, and not depicted in moredetail here because it is well described elsewhere in this invention andis commonly available and conventional in various forms currently. FIG.23F is a frontal view of the guider 338 with cross section view of theportion designated by dashed line, depicting a possible location of aconstricting O-ring 537 which has the function of constricting thedevice very slightly, increasing the frictional forces against theembolic agent (not depicted here) as it moves through. This O-ring 537may be operator controlled for optimum friction, and may be easilychanged during the procedure as needed. If there is back-slip of theembolic agent 1, the O-ring 537 may be tightened until back-slip ceases,without excessive tightening that could lead to difficulties with properadvancement of embolic agent 1 during portion of cycle when this isintended.

Another mechanism for prevention of back-sliding of embolic agent 1 isdepicted in FIGS. 23G-H, which depict some select relevant elements fromFIGS. 23A-E with new elements added to help accomplish the said purpose.Many elements, including the pusher element 90 of FIGS. 23A-E, areomitted from the drawing to help show the new elements, however allelements of FIGS. 23A-E would be present in this embodiment. Theelements seen in FIGS. 23G-H that were already described in FIGS. 23A-Einclude a board 411, a cam 407, a guider 338, an upper rotational joint414 for the cam 407, and an embolic agent 1. New elements include a camarm 417 which is a rigid, hard component rigidly attached to the cam407, and whose motions are purely determined by the motions of the cam407, and a wheel 418 which can rotate freely about its shaft 333, withsaid shaft connected to the cam arm 417 as shown, allowing onlyrotational motion of the wheel 418 relative to the cam arm 417.Additional new elements include two spring mounts 419 which are rigidlyattached to the board 411, a first spring 421 and a second spring 423attached to their spring mounts 419, 4 simple guiders 416, a gripper420, and a swing arm 422 attached to a rotational joint 342, which isattached to the board 411.

The cam 407 and its upper rotational joint 414 and the guider 338 areconfigured and attached to the board 411 as already described in FIGS.23A-E. In FIG. 23G, the system is shown during its downward (Y axis)linear motion as described earlier, when it is desirable for the embolicagent 1 to remain stationary and not be dragged down (Y-axis) by thefrictional forces of the pusher element within it (not shown here). Thecam has rotated counter clockwise as previously described, and this hasswung the cam arm 417 towards the swing arm 422, which is now engaged bythe wheel 418 that rotates freely and passively on its shaft 333 whichis connected to the swing arm 422. This forces the rigid swing arm 422to swing counter clockwise into the position shown, against the opposingforce of the first spring 421. This first spring 421 is a tensionspring, pulling the swing arm 422 rather than pushing on it. The swingarm is shown pressed against the numerous simple guiders 416, which arerigid structures in the shape of a torus in this example although manydifferent shapes or pluralities could provide similar function. Thesimple guiders 416 are rigidly attached to the board 411 and will notmove. The swing arm 422 is pushing the gripper 420, which is slidablymounted to the board 411 so that it may move sideways (in the X-axis)slightly. When pushed by the swing arm 422 as shown, the center of thegripper 420 is aligned eccentrically along the Y axis with the centersof the simple guiders 416 so that there is compression of the embolicagent 1 and increase in frictional force on the embolic agent 1 whichpasses through all of them. The embolic agent 1 is therefore held inposition during this portion of the cycle, so that back-slippage isminimized while the pusher element is retracted.

Of note in FIG. 23G is that the swing arm 422 is in a directly verticalposition, parallel to the linear motion along the Y-axis of someelements such as the cam arm 417 and wheel 418. The wheel 418 rollsalong the surface of the swing arm 422 so that the two may always be incontact despite their different motions in the Y-axis. This will keepthe swing arm 422 pressed against the simple guiders 416 and gripper 420as shown during this linear motion cycle so long as the cam 407 and camarm 417 are rotated in this position.

Moving to FIG. 23H, the same elements are shown, and are therefore notlabeled again. However, they are in different positions as shown,corresponding to the opposing phase of the cycle when the linearelements, such as the cam 407 and cam arm 417, are moving upwards alongthe Y-axis. As reviewed previously, this is when the pusher element andembolic agent 1 are being advanced upward simultaneously as indicated bythe nearby solid arrow. In FIG. 23H, the cam 407 has rotated clockwise,swinging the cam arm 417 as shown, permitting the swing arm 422 to bepulled to the left by the first spring 421. The cam arm 417 has movedupward with the cam 407 in the Y-axis, but the swing arm has not sinceit is secured to the board by the rotational joint 342. The gripper 420is no longer under the influence of the swing arm 422 and is thereforepushed by the attached second spring 423 rightward towards the springmount 419. This second spring 423 is an extension spring, meaning itpushes the gripper 420 rather than pulling it. The gripper is mounted insuch a manner, using a conventional detention mechanism (not depicted),that it may not be pushed any farther to the left than as depicted inthe figure. As shown, its center is now in alignment with the centers ofthe many simple guiders, so that in this position, there is little ifany gripping force exerted on the embolic agent 1, which may thereforefreely move upwards as determined by the mechanisms described in FIGS.23A-E.

Another mechanism that could be employed to prevent back-sliding of theembolic agent 1 during part of the cycle is accomplished by the use ofdirectional traction elements on the pusher element 90, embolic agent 1,or both. These elements and their functions are described in detailelsewhere in this invention, and will therefore be mentioned onlybriefly here. The traction elements may be configured in a manner thatpromotes low friction when the pusher element 90 is retracted downward(Y-axis) and it is desirable for the embolic agent 1 to remainstationary. The traction elements would however increase frictionbetween the two elements when they are advanced upward together, so thatmotion of the pusher element 90 results in upward motion of the embolicagent 1. This mechanism may obviate the need for the variationsdescribed in FIGS. 23F-H. Variations on the above may occur and remainwithin the scope of the invention. The track mechanism may be of anyother conventional type including rollers, wheels, or use of differenttrack and track pin configurations that provide similar purely linearmotion of the linear trolley 410. Instead of using a cam, a simplerlever or arm could be substituted, which would press against the embolicagent 1 similarly, but would simply have a different shape than thedepicted cam.

FIG. 23I depicts one embodiment of the embolic delivery system 324 shownin FIG. 23A-E. It performs essentially the same functions, however usesa different mechanism from the cam and cam block to provideunidirectional grip of the embolic delivery system 324, providingincremental forward motion of the embolic agent 1 when the system movesupward, while avoiding pulling the embolic agent 1 downward when thesystem moves downward, in a manner that employs a different method ofautomatic grasping during one direction and automatic release offriction during other direction. In FIG. 23I, automatic grasping of theembolic agent 1, which may also contain a pusher element (not depicted)as in FIGS. 23A-E, is achieved with one or more encircling structures,herein termed gripping rings 424, which have a large enough hole topermit free passage of the embolic agent 1 when oriented orthogonally toits long axis. Each gripping ring 424 is rigidly integrated with a longsegment 425 that connects via a rotational joint 342 to a rigid push-rod426. The rotational joint allows rotational motion between the longsegment 425 of the gripping ring 424 and the push-rod 426, with freemotion intended to have low friction. There is a detention element 427that is rigidly attached to the push-rod 426 that prevents the longsegment 425 from rotating any higher than the “3 o'clock” position shownon the left. However, the long segment 425 may rotate downward as shownon the right, prevented from rotating further only by the effect of theembolic agent 1 occupying the hole of the gripping ring 424 andpreventing further rotation, since the push-rod 426 and embolic agent 1are both restrained from motion in the x axis by mechanisms alreadydepicted in FIGS. 23A-E to keep them oriented parallel to each otherwith only linear motion in the Y-axis possible. The push-rod 426 isattached to a linear track system (not depicted) similarly to that forthe cam block in FIGS. 23A-E.

On the left in FIG. 23I, the system is shown during the phase where thepush-rod is moving downward, as similar to the cam in FIG. 23A-E, and asindicated by the solid arrow. There is no substantial motion of theembolic agent 1, because there is enough space within the hole of thegripping rings 424 to permit their easy sliding motion over the embolicagent 1. This configuration is also seen in the cross section drawing.The detention elements 427 prevent the gripping rings 424 from beingpushed by frictional forces from the embolic agent 1 into an angledorientation that would result in gripping of the embolic agent 1. Movingto the figure on the right of FIG. 23I, the phase is shown whereby thepush-rod 426 is being pushed upward linearly as shown by the solidarrow. Frictional forces from the embolic agent 1 cause the grippingrings 424 to assume the angles shown, in the absence of detentionelements 427 to prevent such direction of motion, and resulting in anarrowing of the effective diameter of the gripping rings 424 in theX-axis, in turn resulting in a gripping action (high friction) againstthe embolic agent, which is further enhanced by greater force of thepush-rod 426. This results in an upward motion of the embolic agent 1 asshown by the solid arrow. Many of the elements of this system are notdepicted, but are similar to the elements of FIGS. 23A-E and aretherefore not shown again here for brevity, as they can be easilymodified slightly using conventional techniques standard in the art toassimilate the novel elements and mechanism of FIG. 23I.

FIG. 24A introduces an embodiment of embolic delivery system 324 thathas the novel capacity of rapid sequential delivery of multiple embolicagents 1 of a more conventional length, that are much shorter than mostof the other embodiments described in this invention, and which may havememory for a coiled or complex configuration. The embolic deliverysystem 324 has a proximal portion 385, a middle portion 388, and adistal end 389. It includes a housing 384 with a wall 372, a hollow core428, and a cylinder hole 429, springs 421, ball bearings 430, a ballhousing 431, and a piston 360 with a distal end 434. It also includes acylinder 361 which includes concavities running its length called feederchutes 348, and rounded concavities called ball concavities 432 thatmate with a portion of the surfaces of the ball bearings 430. Thelocation of entry of the piston 360 into the feeder chute 348 in thethree O'clock position is called the inlet port 345. The wall 372 of theembolic delivery system 324 is integrated with the wall 505 of theembolic containment apparatus 500, which includes a delivery channel508. Other elements of this embolic delivery system 324 pertaining tothe drive apparatus for the piston 360, and elements that accept theembolic agent 1 after it is advanced beyond this embolic delivery system324 will be described in more detail in later figures. The housing 384of the apparatus, and the cylinder shaft 433 are mounted to the rigidboard 411 that is common to other elements in other figures describedherein that relate to this current invention in order to maintainconstant positioning of elements in relation to each other. The cylindershaft 433 are mounted to the board 411 using conventional pillow mounts(not depicted) that permit free rotation of the shaft 433.

The embolic agent 1 is similar to that previously described in FIG. 4Cor FIG. 9D. In FIG. 24A, the embolic agent 1 is packaged slidably insidean introducer sleeve 327, the combination being called a cartridge 26.The embolic agent 1 may be of any filamentous variety described in thisinvention, including the type shown in FIG. 2M-O, or FIG. 2A-D as wellas many other pushable embolic agents lacking special detachmentmechanisms. The embolic agent 1 is straight when packaged inside therigid or semi-rigid introducer sleeve 327, but may assume a coiled orother variant configuration when unconstrained. In FIG. 24A, thecartridges 26 are seen loosely contained and longitudinally orientedwithin the walls of the embolic containment apparatus 500, and fallingby gravity (as shown) or by a spring loading mechanism (variation notdepicted) through the delivery channel 508 to the integrated embolicdelivery system 324, where one cartridge 26 at a time may come to restwithin the feeder chute 348 of the cylinder 361. The ends of the feederchutes 348 may have slight tapers (not shown) beyond the ends of thecartridges 26 to prevent longitudinal sliding of the cartridges 26during piston 360 travel. In this embodiment, there are 4 feeder chutes348 equally spaced around the cylinder 361 as shown. The cylinder 361may be rotated about its long axis within the cylinder hole 429, andeach quarter turn will place the next feeder chute 348 into positionunder the delivery channel 508. The rotation may occur as the cylindershaft 433 is forcibly rotated clockwise by a drive mechanism (shown inlater figures). The cylinder shaft 433 is rigidly connected to thecylinder 361. Although the drive mechanism (shown in FIG. 24G) mayperform precise quarter rotations of the cylinder 361, the precision maybe enhanced by the mechanism shown. In the middle portion 388 of theembolic delivery system 324 there is a ball housing 431 which containsin its hollow core 428, a spring 421 and a ball bearing 430, best seenin the cross section view. The ball bearing 430 may move up and downwithin the hollow core 428 of the ball housing 431 where it and thespring 421 are contained. The spring 421 is an extension spring, meaningit pushes on the ball bearing 430 against the cylinder 361 as shown. Thecylinder 361 has four ball concavities 432 in its mid portion, equallyspaced around the cylinder 361 between the feeder chutes 348 as shown.Each ball concavity 432 is a bowl-shaped depression which matches theouter convex surface of the ball bearing 430 in contour. When thecylinder 361 is positioned so that one of its four ball concavities 432is under the ball bearing 430, the ball bearing 430 is pushed by thespring 421 into the ball concavity 432 and locking the cylinder 361 intothe optimum position within housing 384 to line up the delivery channel508 with the feeder chute 348 for seamless transfer of cartridge 26.Since the ball is spherical in shape, it will help to maintain thecylinder 361 in the proper longitudinal position as well as rotationalposition. In the depicted embodiment, an identical mechanism is located180 degrees across the system, to further facilitate the said functionby providing opposing forces of similar magnitude, thus stabilizing thecylinder 361 within the housing 384 by substantially removing the burdenon the cylinder shaft 433 with regard to providing stabilizing force.

The force of the spring 421 is not great enough to prevent activerotation of the cylinder 361 once sufficient rotational force is appliedto the cylinder shaft 433 by the drive mechanism (depicted in laterfigures). When rotational force is applied, it may overcome the force ofthe spring 421 that is pushing the ball bearing 430, which will roll orslide against the ball concavity 432 as it moves backwards against theforce of the spring 421 within the ball housing 431. Once a ¼ turn hasbeen achieved, the ball bearing 430 will once again lock into the nextball concavity 432 and maintain stability and precise positioning ofcylinder 361 within housing 384.

In FIGS. 24A-F, the function of this system is further described anddepicted. FIG. 24A consists of a 3-dimensional frontal perspective viewwith 2-dimensional cross section views at levels as indicated by dashedlines. FIGS. 24B-F consists of a 2-dimensional side projection viewswith 2-dimensional cross section views at levels as indicated by dashedlines. The drive mechanism will be described in detail in FIG. 24G. FIG.24A corresponds to the beginning of the cycle. The cartridge 26containing the embolic agent 1 inside an introducer sleeve 327 is seenloaded in the feeder chute 348 at the 12 o'clock position, with theother 3 feeder chutes 348 empty. In the next phase of the cycle, in FIG.24B, the piston 360 has been thrust forward through the feeder chute 348in the 3 o'clock position. The distal end 434 of the piston 360 haspassed beyond the distal end 389 of the embolic delivery system 324 andthrough the lumen 371 of the outlet port 346, and may be capable offurther excursion as will be discussed later. The mechanism that keepsthe piston precisely aligned, and moves it forward, will be describedlater. In this phase of the first cycle, the piston 360 has entered anempty feeder chute 348 and therefore does not push anything. In the nextphase of the cycle, in FIG. 24C, the system is depicted after a 30degree clockwise rotation of the cylinder 361. Prior to this rotation ofthe cylinder 361, the piston 360 is situated outside of the feeder chute348 as shown. The cylinder 361 will always turn in ¼ rotationincrements, so this figure is showing it in mid phase during activerotation of the cylinder 361 for purposes of teaching. The feeder chute348 containing the cartridge 26 bearing the embolic agent 1 and theintroducer sleeve 327 is now seen in approximately the one o'clockposition. The rotation of the cylinder 361 has caused the ball concavity432 to rotate away from the ball bearing 430, pushing the ball bearing430 backwards in the ball housing 431. It may now roll or slide againstthe cylinder 361 surface, and over the next feeder chute 348 to come itsway, since the feeder chute 348 radius is small relative to that of theball bearing 430.

Moving to the next phase in the sequence, in FIG. 24D, the system hascome to rest momentarily now that a ¼ turn relative to FIG. 24A has beenachieved. It has come to rest because the drive mechanism (shown in FIG.24G) that turns the cylinder shaft 433 performs quarter turns. The ballbearings 430 have settled into the ball concavities 432 to maintain theprecise position of cylinder 361. Progressing to the next phase, in FIG.24E, the piston 360 has been driven forward into the feeder chute 348 inthe direction towards the distal portion 389. Since a cartridge 26containing embolic agent 1 inside an introducer sleeve 327 was rotatedpreviously to the 3 o'clock position where the piston advances, thepiston 360 is seen pushing the embolic agent 1 forward in the directionof the distal portion 389 of the embolic delivery system 324. At themoment of this depiction, the distal end 434 of the piston 360 is at thedistal end 389 of the embolic delivery system 324, and is pushing theproximal end 18 of the embolic agent 1, which can be seen extendingbeyond the outlet port 346. Further excursion is possible and wouldresult in subsequent pushing of proximal end 18 of the embolic agent 1into a receiving catheter or side-port adaptor (not shown) which willthen feed it to the introducer catheter (not shown) and finally into thebody, as will be discussed further later. The piston 360, whose diameteris approximately similar to that of the embolic agent 1 and smaller thanthe diameter of the introducer sleeve 327, is aligned precisely bymechanisms depicted later, to enter the center of the cartridge 26, inthe hollow center of the introducer sleeve 327, to push the embolicagent 1 forward. Thus the embolic agent 1 and the piston 360 are bothsliding inside the introducer sleeve 327, which is kept in place by adetention mechanism at the end, which can be of conventional type, andis not shown clearly in this figure, but can be as simple as a narrowingat the distal end 389 of the system that is large enough to allowpassage of the embolic agent 1 but not of the larger caliber introducersleeve 327, which will therefore remain substantially motionless in thefeeder chute 348 during this phase.

Once the distal end 434 of the piston 360 has traveled its course untilit has pushed the embolic agent 1 completely out of the embolic deliverysystem 324 and into the receiving elements (not shown), then it may bewithdrawn back to the position as shown in the next drawing in the cycleshown in FIG. 24F. Upon its withdrawal, the now empty introducer sleeve327 may have a tendency to stick to the piston 360 enough to bedislodged backwards. Such motion of the introducer sleeve 327 could beprevented by a caliber narrowing (not shown) at the proximal end of theembolic delivery system 324 that, like the one at the distal end 389already described, is large enough to accept the piston 360 but not thelarger caliber introducer sleeve 327.

After the full withdrawal of the piston 360 to the position depicted,the cylinder 361 has rotated another quarter turn so that the emptyintroducer sleeve 327 that was previously in the three o'clock positionis now in the six o'clock position where the housing 384 is incompleteand there is nothing to hold the introducer sleeve 327 in the feederchute 348, as seen in FIG. 24F. It may drop out due to gravity, or itmay be dislodged by a small probe or conventional flat or sharp element(not shown) as it rotates by. Also shown is the cartridge 26 containingan embolic agent 1 inside an introducer sleeve 327 is now in the feederchute 348 in the 3 o'clock position, having just rotated over from thetwelve O'clock position.

As all future cycles are repeated, the same actions of the elements ofthe embolic delivery system 324 will occur with each phase: First, thecylinder 361 will rotate a quarter turn, resulting in a new cartridge 26loading into the feeder chute 348 at the twelve O'clock position, aloaded cartridge 26 being positioned at 3 o'clock, and an emptyintroducer sleeve 327 being ejected at the six o'clock position. Second,once the cylinder 361 has come to rest during each phase, the piston 360will push the embolic agent 1 out of its introducer sleeve 327 and outof the embolic delivery system 324, and then, third, the piston 360 willretract. These actions described in this paragraph are represented by acontinuous cycling from FIG. 24F to FIG. 24E, to FIG. 24F to FIG. 24 E,in ongoing fashion as required by the operator. With each cycle, a newembolic agent 1 is delivered forward into the introducer catheter orintermediate elements (not shown), and a new loaded cartridge 26 comesinto place for another delivery of embolic agent 1.

As shown in FIG. 24A, a rigid board 411 serves as a framework forattachment of all components that must be maintained rigidly fixed inposition relative to each other, including the cylinder housing 384 andthe cylinder shaft 433 mounts. These are un-depicted conventional shaftmounts that allow rotation of the shaft 433 without allowing othersubstantial motion of the shaft. Also mounted rigidly to the board 411is the linear track to be described in FIG. 24G, which will maintain theproper relationship between elements described in FIGS. 24A-F and otherdrive elements in FIG. 24G.

These novel functions and elements are controlled by drive mechanismsdescribed in FIG. 24G. Importantly, all of the actions described inFIGS. 24 A-F are very simply accomplished by two basic linear handmotions of the operator 600. A forward linear hand motion will advancethe piston, thus delivering the embolic agent 1, and then withoutchanging grip or hand position on the device, a backwards linear handmotion will result in the withdrawal of the piston, followed by rotationof the cylinder 361 and all other functions described above in FIGS. 24A-F, so that the system is now in readiness for another cycle uponrepeated linear motion of her hand. The system will allow the operator600 to have exquisite control over the speed and force of advancement ofthe embolic agent, which can be important for safe delivery. The tactilesense of the resistance to advancement of the embolic agent 1 will bepreserved, as is often desired by experienced operators. Thus the novelfunctions of automation and greatly enhanced expedience of repeatedembolic delivery may be accomplished while preserving desirable controlaspects in this novel invention.

In variation, the ball bearing 430 may be replaced with a pin orcylinder with its long axis oriented along the long axis of the cylinder361, and likewise instead of a ball concavity 432, a longer groove thatmated with the pin or cylinder could be utilized, and still be inkeeping with the overall important and novel features of the invention.In another variation, the feeding mechanism of the embolic agents 1 fromthe embolic containment apparatus 500 to the embolic delivery system 324would not rely on gravity, but instead could utilize a spring loadedsystem more similar to that depicted in FIG. 25A or of other design withsimilar function. Many other variations in specific element design andconfiguration are possible that would still be in keeping with the noveland important functional aspects of this invention as outlined herein.

FIG. 24G depicts the driving mechanism of the embolic delivery system324 that was partially described in FIGS. 24A-F, and includes a sideview (top drawing), overhead view (middle drawing), and frontal (crosssectional) view, with further explanation of view indicated by thelabeled coordinates. The dashed lines indicate the locations where theviews correspond to each other. As described in detail previously, themain functions of this sub-system are, in very simplified form, to pushthe embolic agent through the embolic delivery system 324 and on to thereceiving elements beyond (not shown), as well as to cause quarterrotation increments of the cylinder 361, in sequence and repeatedly. Therigid, cylindrical piston 360 is attached rigidly to the linear trolley410 which may move only linearly and slidably along a linear track 406,which is rigidly attached to a rigid board 411 that provides a rigidframework for attachment of all elements that need to be secured rigidlyin position. The board 411 is depicted on the overhead view only forsimplification. The track 406 is attached to the same board 411 as arethe cylinder housing 384 and the mounts for the cylinder shaft 433 (seeFIGS. 24A-F). Other elements are attached to the board as describedindividually. As depicted in FIG. 24G, the mechanism for slidability ofthe linear trolley 410 on the track 406 is a simple sliding function,aided by use of low friction surfaces and precision construction ofmating surfaces. However, in variation, this linear motion could beenhanced by addition of conventional roller elements such as bearings orwheels that are not depicted.

The hand 601 of the operator 600 may grasp the handle 447 to move thelinear trolley 410 along the linear track 406 in either direction.“Forward” will refer to a leftward direction in the top and side views,and “backward” will be the opposite, and this will correspond to thesame descriptions put forth in FIGS. 24A-F. In another contemplatedembodiment (not depicted), a conventional automated system may performthe same function of to-and-fro linear motion in a repeated manner, inlieu of the operator's hand 601, and this system may be controllable bythe operator 600 using conventional control mechanisms. In FIG. 24G, aforward motion of the linear trolley 410 will move the attached piston360 forward. The piston's 360 further functions of pushing the embolicagent through the cylinder 361 were described previously and notrepeated in detail here. The piston distal end 434 is indicated, and inFIG. 24G is seen to be located immediately outside of the confines ofthe cylinder 361. Any further forward motion of the piston 360 wouldplace it in the feeder chute 348 of the cylinder 361 as describedpreviously. Any backward motion from this position will simply move itfarther away from the cylinder 361, but it will remain aligned linearlyalong the axis of the cylinder 361 so that subsequent re-advancementwill again place it into the feeder chute 348 of the cylinder 361. Alsoshown on the top view of FIG. 24G are the trolley end stops 435 on bothends of the linear track 406. These are rigidly attached to the track406 and define the limits of travel of the linear 410 that cannot movebeyond the edge of the trolley end stops 435. Also shown on side and topviews, and incompletely on the frontal view, are the elements thatfacilitate cylinder 361 rotation including the rack 438, pinion 439,pinion shaft 333, reel 442, tether 436, tether guides 437, clutch 440,clutch arm 441, spring 421, and spring mount 419. The pinion 439 isattached rigidly to its shaft 333, which is also attached rigidly to areel 442 as shown. The shaft 333 is attached to the board 411 usingconventional mount (not depicted) that allows conventional rotation ofthe shaft, but allows no other motion of the shaft. Therefore any forcethat causes rotation of the pinion 439 will rotate the reel 442 in thesame manner. Rotation of the pinion 439 is caused by the rack 438 whichis rigidly attached to the linear trolley 410, which slides linearlyalong the linear track 406, as when the operator 600 moves the lineartrolley 410. The tether 436 is attached to the reel 442 as shown, sothat rotation of the reel 442 will shorten or lengthen the tether 436depending on direction of rotation. The tether 436 is a filament, ofmany possible compounds that provide flexibility like a string or thinwire or thin wire rope, and that is substantially resistant tolongitudinal stretching. The other end of the tether 436 is attached tothe clutch arm 441 so that tension on the tether will pull the clutcharm 441 and cause rotation of the clutch 440 to which it is rigidlyattached. The clutch 440 is attached to the cylinder shaft 433 as shown.The clutch 440 permits unidirectional rotation between its outer memberrigidly attached to the clutch arm 441 and its inner member rigidlyattached to the cylinder shaft 433. The details of the workings of theclutch 440 are not depicted as it is a conventional element well knownin the art of automation machines. It permits free clockwise (frontalview) rotation of the outer member (and attached clutch arm 441)relative to inner, but locks the inner and outer members rigidly uponcounterclockwise rotation of the clutch arm 441. Therefore, clockwiserotation of the clutch arm 441 would cause no rotation of the cylindershaft 433 or cylinder 361, whereas counterclockwise rotation of theclutch arm 441 would cause similar rotation of cylinder shaft 433 andcylinder 361. This latter motion would correspond to the ‘clockwise’rotation described during normal function of the cylinder 361 in FIGS.24A-F because the perspective is different in those figures. Repeatedoscillation of the clutch arm 441 between the approximate seven thirtyo'clock position seen in FIG. 24G and the four thirty o'clock positionresults in incremental quarter rotations of the cylinder 361 in thecounterclockwise direction without any rotation in the clockwisedirection, which is the desired rotation sequence described previouslyin FIGS. 24A-F. The currently described elements in FIG. 24G providethis functionality, in addition to others to be described. Also,depicted are three tether guides 437. These are simple cylindrical rigidobjects attached rigidly to the board 411 and do not move. They have lowfriction surface, permitting sliding of the tether 436 around it, andguiding the course of the tether 436. They are oriented as shown, withtwo in parallel and those two orthogonal to the third, to perform saidfunction. Of note, the tip of the clutch arm 441 where the tether 436attaches will move somewhat up and down in the Z-axis as it rotatesabout the cylinder shaft 433, and therefore these guides will alsopermit the corresponding expected sliding motion of the tether 436 tooccur. In variation the depicted tether guides 437 may be replaced by asingle ring.

Therefore, by way of summary, a backward motion of the operator's hand601 and linear trolley 410 from the position depicted will cause similarbackwards linear motion of the rack 438, which will cause rotation ofthe pinion, thus rotating the reel clockwise as would be seen in sideview. This will take up (shorten) the tether 436, thus pulling tensionon the clutch arm 441, which will pull it rightward of the depictedseven thirty o'clock position (frontal view) towards its final locationin the four thirty o'clock position. The length of the rack 438,circumferences of pinion 439 and reel 442, length of clutch arm 441 areall designed to result in one pass of the rack 438 over the pinion 439to result in quarter rotation of the cylinder 361. Once the rack 438 hascompletely passed backwards over the pinion 439, the pinion will stopmoving, and the linear trolley 410 will reach the trolley end stop 435.The same backward motion of operator's hand 601 also results in linearbackwards motion of the piston 360 as described in FIGS. 24A-F.

Forward motion of the linear trolley 410 from the final positiondescribed immediately above will therefore result in the opposite motionof the pinion 439, rotating it counterclockwise (side view), andslackening the tether 436. The spring 421 is attached on one of its endsto the spring mount 419 which is rigidly attached to the board 411, andon its other end to the end of the clutch arm 441. Since it is a tensionspring, it will pull the clutch arm 441 towards the spring mount 419.This may now occur since the tether 436 has been slackened, so theclutch arm 441 will rotate back to its seven thirty o'clock position asdepicted, once the rack 438 has passed over the pinion 439 to return tothe position depicted in FIG. 24G. Importantly, due to the function ofthe clutch 440, the cylinder 361 did not move upon this last motion ofthe clutch arm 441.

Further forward motion of the linear trolley 410 along the track 406will advance the piston 360 into the feeder chute 348 of the cylinder361 and perform the functions described in more detail in FIGS. 24A-Fthat result in deployment of embolic agent. Referring again to FIG. 24G,since the rack 438 and pinion 439 are no longer engaged, there is noeffect on cylinder 361 rotation during this portion of the excursion.Upon full forward motion, the linear trolley 410 is stopped by thetrolley end stop 435, and motion may now be reversed by the operator 600to retract the piston, until the rack 438 and pinion 439 engage againand the cycle is repeated.

Thus described is an embolic delivery system 324 in FIGS. 24 A-G thatperforms the novel function of converting a simple to-and-fro hand 601motion into the many complex functions described, which ultimately havethe novel effect of very rapidly and repeatedly delivering embolicagents 1 to a body cavity via an introducer catheter, allowing rapiddelivery of a great many embolic agents to treat sizable cavities in anexpedient and controlled manner, while maintaining the tactile sense ofcontrol by the operator 600 during the delicate process of passing theembolic agent 1 into the tissues without causing harm due to excessiveforce or excessive bulk of embolic agent. Once the set-up isaccomplished, the to-and-fro hand 601 motions are all that are requiredto repeatedly deliver embolic agent, as opposed to the current standardpractice that involves many steps by the operator 600 in loadingindividual embolic agents and pushing them through the catheters.Although not outlined in detail herein, this standard process hasnumerous steps and takes longer per each embolic delivery by a verylarge factor, such that the described invention could shorten aprolonged procedure by an hour or even more in some situations, and makea procedure which is currently impractical become practical, thusexpanding the possibilities of what diseases may be treated with embolictechnique.

FIG. 25A include views of an embolic delivery device 324 that candeliver multiple embolic agents 1 in rapid sequence, without introducersleeves. In this embodiment, the embolic agents 1 are composed of ahelical wire 33 with end pieces 61 tethered to a central wire 6, aresubstantially straight and cylindrical in their resting state, so theydo not need to be constrained inside an introducer sleeve to be easilyhandled in a straight configuration. The embolic agents 1 are stored inan embolic containment apparatus 500 consisting of a wall 505, and ahollow delivery channel 508 where the embolic agents 1 reside and passtowards the feeder chute 348 of the embolic delivery device 324. Theembolic agents 1 feed to the feeder chute 348 by an extension spring 507in the embolic containment apparatus 500 which presses down on a plate509 as shown, said plate 509 being slidably mounted within the deliverychannel 508 so that it may incrementally move towards the feeder chute348 of the embolic delivery system 324. In the second drawing of thesequence, a substantially cylindrical piston 360 of the embolic deliverysystem 324 is moved forward by a mechanical linkage (not depicted here)or by the operator's hand motions, to push the embolic agent 1 withinthe feeder chute 348 forward, to a connection between the embolicdelivery system 324 and introducer catheter 200 (not shown) orintermediate elements as described in this invention. Once the piston360 is withdrawn to its original position as seen in the third drawingof the sequence, another embolic agent 1 is allowed to fill the nowempty space in the feeder chute 348, and the cycle may be repeated. Alsoshown is a movable retainer 376, which is a long, narrow rigid plate. Itis shown in the top drawing positioned over the embolic agent 1 in thefeeder chute 348. It functions to more precisely align the embolic agent1 in the feeder chute 348 for smooth forward motion beyond the feederchute 348, and to maintain the semi-rigid or flexible embolic agent 1 ina very straight configuration within the feeder chute 348 so thatforward motion of the piston 360 translates well as forward motion ofthe embolic agent 1. In the second drawing in the sequence, the movableretainer 376 is in same position as the piston 360 has been advancedforward, pushing embolic agent 1. In the third drawing, the movableretainer 376 has retracted outwards through the opening 377 in the wall372 of the embolic delivery system 324 just above the feeder chute 348.This allows the next embolic agent 1 to drop into the feeder chute 348as shown, ready for the next cycle to be repeated. The mechanical driverfor the motion of the movable retainer 376 is not depicted in thissimple figure, but may use conventional motion systems widely known inthe art, and importantly, may be linked with the motion of the piston360 so that withdrawing the piston also results in the outward motion ofthe movable retainer 376 without the need for additional manipulationsby the operator.

It is well known in the art that conventional wire-coil type embolicagents do not always serve well in pushing other similar embolic agentsthrough a catheter. I.e., they are usually pushed through one at a timeby a pusher element until the embolic agent is completely extruded fromthe introducer catheter. It is known that attempts to push them inseries may result in jamming within the catheter when the proximalportion of one agent overlaps with the distal end of the other. Howeverin FIG. 25A, each embolic agent 1 serves to push the former one throughthe introducer catheter. They must therefore be designed to accomplishthis task without failing as described, i.e., the ends must not overlap,and a smooth flow of agents must occur. To this end, such a device willrequire embolic agents as described elsewhere herein with features topermit serial delivery. In this embodiment, the end pieces 61 are discshaped instead of the conventional rounded configuration as seen in FIG.9D. Many different types of embolic agent 1 may be used with thisembolic delivery system 324. They may have microfibers attached topromote thrombogenicity. They may be composed of polymer, or be similarto shown in FIGS. 3A-B where agents particularly suited for serialdelivery are shown.

FIG. 25B is a variation of the embodiment shown in FIG. 25A that addsfunctionality of detachability and added control. The major differencebeing the use of embolic agent 1 that has traction elements 270consisting of bidirectional locking elements 122 as described elsewhereherein. Otherwise there are no substantial differences in the embolicdelivery system 1 or embolic containment apparatus 500 from FIG. 25A. InFIG. 25B, when the embolic agent 1 falls or is pushed into the feederchute 348, its bidirectional locking element 122 automatically engageswith the bidirectional locking element 122 of the embolic agent 1preceding it. The bidirectional locking element 122 on the distal end 19of the embolic agent 1 is oriented as a mirror image with thebidirectional locking element 122 on the proximal end 18, so they engageas shown. In order to orient them for proper matching, rotation of theembolic agents 1 around their long axes is prevented while they arestill within the embolic delivery system 324, as indicated by therotational arrow stricken with an “X”. This is accomplished in thisexample by altering the cross-sectional shape of the embolic agent 1 asshown, where it is not completely round, but instead has partiallystraight sides as seen best in the magnified image denoted by the dashedlines. The walls 505 of the delivery channel 508 and the feeder chute348 are narrow enough to prevent rotation of the embolic agents 1 alongtheir long axes, so they will maintain the same orientation that wasgiven to them at the time of manufacture when they were loaded into theembolic containment apparatus 500. Once they are attached together, theembolic agents 1 will function as described in FIG. 8B permittingfunctions of detachability at the tip of the introducer catheter (notshown here), and ability of operator to advance or retract the series ofattached embolic agents 1 by manipulation of the proximal embolic agents1 in the operating field. By disconnecting the embolic delivery system324 from the introducer catheter (not shown), manual control of theproximal embolic agents 1 may be achieved. They may be retracted, ormanually advanced using a conventional pusher element (not shown) in aconventional manner.

FIG. 25C is a sequential set of two dimensional longitudinal sections,with cross sections in three locations designated by the linescorresponding to the top drawing. It depicts an embolic delivery system324 that delivers, in a rapidly repeating manner, numerous separateembolic agents 1 that may be relatively short in total length, and thatmay be straight when inside an introducer catheter 200 or introducersleeve 327, and may assume any of the shapes described elsewhere hereinwhen in their free state or when unconstrained in the target tissues 589in the body 580. A major difference with FIGS. 25A-B is that it can workwith embolic agents 1 within introducer sleeves 327 as a loadedcartridge 26, which may facilitate serial delivery of embolic agents 1with memory for shapes other than linear, such as loops or coils, sincethey will be constrained within their introducer sleeves 327 orintroducer catheter 200 or other elements described in this inventionwhich maintain embolic agents 1 in straight configurations untildeployed into the target tissues 589. Beginning from the top drawing,the embolic containment apparatus 500 has a wall 505 that housesnumerous embolic agents 1, each of which is contained in its ownintroducer sleeve 327, the assembled combination being called acartridge 26. The walls 505 form a delivery channel 508 that the embolicagents 1 travel down incrementally towards the feeder chute 348 of theembolic delivery system 324. The cartridges 26 are stacked in theembolic containment apparatus 500 and delivered to the feeder chute 348by mechanisms not depicted here, but were represented in FIGS. 25A-B. InFIG. 25C, in the top drawing, the system has not yet commenced itsaction. A cartridge 26 is situated in the feeder chute 348, and thepiston 360 is partially retracted. An introducer catheter 200 isattached to the embolic delivery system 324 at its outlet port 346, andthe tip of the introducer catheter 211 is in the target tissues 589. Thepiston 360 is capable of only linear motion using conventionalmechanical linkages not shown here.

Progressing to the second drawing in FIG. 25C, the piston 360 has movedlinearly forward, entering the introducer sleeve 327 which is too smallto be pushed forward. The piston 360 is very slightly greater indiameter than the embolic agent 1, and approximately the same as theinner diameter of the hollow introducer sleeve 327. Therefore, thedescribed action pushes the embolic agent 1 through the feeder chute 348into the introducer catheter 200 as shown. In this drawing, severalcycles of action have already been performed and the embolic agents 1,in series, have begun to deploy into the target tissues 589 as shown. Inthe third drawing of FIG. 25C, the piston 360 has partially retracted,pulling the introducer sleeve 327 backward out of the feeder chute 348due to friction between the piston 360 and the introducer sleeve 327.The feeder chute 348 received a new loaded cartridge 26. In the fourthdrawing, the piston 360 has retracted further, resulting in theintroducer sleeve 327 shearing off of the piston 360 due to the smallhole 445 in the housing 384 whose diameter is less than that of theouter diameter of the introducer sleeve 327. The used introducer sleeve327 falls away into a receptacle (not shown) or the environment aswaste. The cycle may be repeated, resulting in more embolic agents 1deployed in target tissues 589. When the desired endpoint ofembolization has been achieved, any residual embolic agent 1 stillremaining in the introducer catheter 200 may simply be removed bywithdrawing the catheter with the embolic agents 1 still inside, or bythe passage of a long pusher element (not shown) through the entireintroducer catheter 200 to push all embolic agents 1 still containedwithin it, into the tissues beyond its tip 211. Any embolic agents 1that can't or shouldn't be passed may then be withdrawn with theintroducer catheter 200, which may be detached from the embolic deliverysystem 324. If the introducer catheter 200 is a microcatheter which isco-axially passed through a larger introducer catheter as commonlypracticed in the art, then catheter access to the target tissues 589 isnot lost even upon withdrawal of the introducer catheter 200 and embolicagents 1 within.

FIGS. 26A-G depict several varieties of embolic detachment tools 160that may be used by the operator in this invention to modify the embolicagent as needed intra-procedurally. FIG. 26A is a perspective view whichschematically depicts a wire-stripper 177 that may be applied to theembolic agent 1 as shown to mechanically strip away a short segment ofcapsule 43, leaving a bare area 39 of wire 6. It has a hinge 178 on oneside to allow opening and closing. FIG. 26B is a cut-away view showingthe internal workings of a wire stripper 177 which includes a sharpround blade 162 that can open and close with the housing 179. FIG. 26Cis a cut-away view showing embolic detachment tool 160 with a sandingelement 180 which is round in cross section, that may be squeezed aroundthe embolic agent 1 by the housing 179, and used to abrade the surfaceof the embolic agent to remove capsule or coating from it. FIG. 26D is afrontal view that depicts a heating element 181 within the housing 179,which may be applied in contact with the embolic agent to melt awaymaterial of low melting point, such as easily removable seal asdescribed in a variation of FIG. 6J. FIG. 26E is a perspective view of awire loop heater 182, which resembles a conventional item in operatingsuites sometimes called cautery pens. The wire 174 becomes hot and maybe used to manually burn off a small segment of capsule or coating froman embolic agent, leaving the metallic components intact. FIG. 26F showsa tool with electrodes 183 attached to a high voltage electrical powersource 176, which may be pulsed, causing sparks to burn through thedielectric coating or capsule of some embolic agents, creating anexposed bare area of wire. FIG. 26G is a cut-away and frontal view of adissolution chamber 184. Its housing 179 has a hub 186 where a syringemay attach to inject liquid into a fluid-tight chamber 184 formed by thehousing 179 and two gaskets 185 which may open and close with thehousing 179 around the embolic agent. Filling of the chamber andexpulsion of air is facilitated by releasing or replacing the vent cap187 onto the vent 188 in the housing 179. Solvent in the chamber 184, asmall segment of embolic agent 1 may result in dissolution of theenclosed segment of capsule.

Details of an example of the interfaces between components such asembolic delivery systems 324 using feeder rollers 325 rotating on shafts333, side port adaptors 530, and introducer catheters 200 are shown in 3frontal views in FIGS. 27A-B. FIG. 27A shows a modified side portadaptor 530 with a rotating locking hub 532 that can connect detachablywith the hub 201 of an introducer catheter 200 that has a wall 208 andlumen 209. The side port adaptor 530 has a wall 543 and lumen 541 and aside port 535, as well as an internal constricting O-ring 537 that iscontrolled by a rotating O-ring constrictor 538 accessible to theoperator. There is an introducer element 347 which is a tube-likeextension that accepts the embolic agent 1 and may have two differentouter diameters as shown, to provide a small outer diameter that allowsit to be positioned in very close proximity to the feeder rollers 325that rotate on their shafts, with said close positioning serving toprevent kinking or buckling of the embolic agent 1. Discussion ofintroducer element and embodiments were shown also in FIGS. 16D-G. TheO-ring constrictor 538 is a conventional element which is used in thisnovel device here to maintain fluid-tight seal when desired, while beingadjustable to find the best balance between seal and friction ofsufficiently small degree against the embolic agent 1 so as to permitits useful motion through the system. Here it is shown constricted,without embolic agent inside its core, such as might occur when thesystem is being flushed with fluid through the side port 535. FIG. 27Bshows the same device with the introducer catheter 200 attached, theO-ring 537 opened, and the embolic agent 1 moving forward through thesystem as indicated by the solid arrow and the curved arrows showingfeeder roller 325 rotation. This system represents a relatively simpleand economical system from manufacturing aspect that neverthelessprovides many of the useful aspects of the invention including abilityto deliver very long embolic agent 1, flush the system, and detachmembers for introduction of other elements or performance of variousother maneuvers commonly performed in practice. In one contemplatedembodiment, a hemostatic valve (not shown) may be substituted for theO-ring constrictor 538. Whichever type of seal is used, it isadvantageous to be capable of withstanding the hydraulic force offorceful injection of fluid into the side port 535 without allowingbackflow.

FIGS. 28A-D details a concept of coil shape utilizing the thermal memoryproperties of nickel titanium alloy, or nitinol, which can be used tofacilitate the objectives of this invention, with regard to the feedingof the embolic agent 1 through the system, which favors a straightfilamentous shape, while also having the benefits of more complexgeometries as described herein once the embolic agent 1 is within thebody cavity. Nitinol may be formulated to be relatively straight or withvery weak shape memory at room temperature, but resume a more robustshape memory, of geometry determined at manufacture, at bodytemperature. This remarkable property has been used with success for acommercial intravenous filter that passed through a catheter as a singlewire and formed a complex functional shape in the body. FIG. 28Aincludes sequential frontal views of an embolic agent 1 with a Nitinolwire 6 in a capsule 43 of polymer, which is substantially straight atroom temperature and when constrained within an introducer catheter (notshown), but when introduced into the warm body (not shown), as indicatedby the arrow, resumes its pre-determined memory shape, in this case aseries of loops. This embolic agent 1 may be modified by the operatorand undergo electrolytic detachment as described herein. Nearly anyvariation of embolic agent 1 composed of an encapsulated wire describedherein could be made using Nitinol substituting for stainless steel. TheNitinol will not usually be used to serve the functions often describedfor metals such as platinum or gold as markers or electrical contacts.FIG. 28B includes sequential frontal views depicting a variation wherebya small diameter strand of stainless steel wire 6 is used as describedpreviously, to permit electrolytic detachment. It is centrally locatedin the capsule 43. A second wire 62, composed of Nitinol, iseccentrically located in the capsule and never touches the central wire6. The arrow indicates modification by the operator using embolicdetachment tools (not shown) which removes a portion of the capsule 43as previously described, creating a bare portion 39 of wire 6, and alsocut the eccentric second wire 62 of Nitinol. Electrolytic detachment ormechanical detachment may occur using means described in this invention.In the body cavity, the second wire 62 of Nitinol provides the shapememory function described above, causing the embolic agent 1 to belooped at body temperature as shown in FIG. 28A. FIG. 28C includessequential frontal views showing the concept being applied to a helicalwire 33 made of Nitinol. The embolic agent 1 is substantially straightor with weak shape memory at room temperature on the left, but as shownby the arrow, assumes a looped memory shape once deployed in the body.FIG. 28D includes sequential views and frontal view showing an embolicagent 1 composed of a helical wire 33 which need not have shape memory,with a Nitinol wire 6 centrally attached at proximal end 18 and distalend 19 of the embolic agent 1, and which is substantially straight atroom temperature and assumes a memory shape at body temperature,creating loops as seen on the right. In other contemplated embodiments,any of the embolic agents in FIGS. 28A-D may also combine otherdescribed aspects of this invention, and may have a variety of possiblememory shapes they assume.

Various embodiments of the invention disclosed herein are furtherdescribed as follows.

An embolic agent apparatus, comprising an embolic agent with at leasttwo or more segments, each segment of the embolic agent having aproximal end, a middle portion, and a distal end; and, a detachmentelement separating each embolic agent segment operable to provide adetachment site selectable by the operator.

The apparatus as above further comprising a linking element operable toconnect the proximal end of the embolic agent to a detachment elementassociated with the distal end of a pusher element operable to allow theoperator to orient the embolic agent with bi-directional motion. Theapparatus of as above further comprising a linking element operable tolink the proximal end of the embolic agent with the distal end of thedetachment element operable to advance the detachment site of theembolic agent intracorporeally.

The apparatus as above wherein the embolic agent includes at least onenode located between the distal and proximate ends of at least onesegment of the embolic agent. The apparatus as above wherein the embolicagent includes at least one notch located between the distal andproximate ends of at least one segment of the embolic agent. Theapparatus as above wherein the detachment element is selected from thegroup consisting of a mechanical detachment element, an electrolyticdetachment element, a bi-directional locking element, a heat sensitiveadhesive, a heat deformable metal, a corrodible metal, a dissolvablemetal, and a dissolvable polymer. The apparatus as above wherein theembolic agent is selected from the group consisting of a monofilament, amultifilament, a helical wire, an encapsulated wire, a coated helicalwire, a chemically dissolvable polymer, an electrolytically corrodiblewire, a polymer, a metal wire, a polyglycolide, a polylactide, a polyL-lactide, a poly DL-lactide, a poly-caprolactone, and a copolymer. Theapparatus as above wherein at least one segment of the embolic agentincludes a removable seal. The apparatus as above wherein the embolicagent further comprises a wire within the body of the embolic agentcapable of conducting electrical current. The apparatus as above whereinthe embolic agent further comprises a traction element located on asurface of the embolic agent. The apparatus as above further comprisinga linking element with an attachment pin and the linking elementpositioned between the embolic agent and the detachment element. Theapparatus as above wherein the linking element includes a tractionelement applied to the attachment pin wherein the traction element isselected from the group consisting of a barb, a ridge, an attachmentpin, a curved attachment pin, a frictional roughness, and a threadedconnection. The apparatus as above wherein the detachment element is oneselected from the group consisting of an adhesive, a sealant, achemically corrodible polymer, an electrolytically corrodible metal, apolymer, polyglycolide, a polylactide, a poly L-lactide, a polyDL-lactide, a poly-caprolactone, and a copolymer. The apparatus as abovewherein the detachment element or embolic agent is modified with anembolic detachment tool selected from the group consisting of a sparkgenerator, a heat gun, a sander, a shaper, a wire stripper, adissolution chamber, a swage tool, an adhesive, a heat chamber, ascissor or a blade. The apparatus as above wherein the comprising acatheter for guiding the embolic agent to the target tissue wherein thecatheter includes an electrical current conducting wire secured withinthe wall of the catheter up to the catheter tip, operable to allow theoperator to place the tip of the catheter at the desired detachmentelement and electrolytically detach the embolic agent intracorporeally.The apparatus as above wherein the comprising a catheter for guiding theembolic agent to the target tissue wherein the catheter delivers asolvent to the selected detachment element, operable to allow theoperator to place the tip of the catheter at the desired detachmentelement and chemically detach the embolic agent intracorporeally.

A catheter apparatus comprising a lumen and a wall forming a tubestructure with a proximal end, a middle portion and a distal end; atleast one wire encapsulated within the wall portion capable ofconducting electricity; and, a contact attached to the proximal end ofthe tube and a contact attached to the distal end of the tube so as toprovide electrical energy to an embolic agent, a detachment element orthe local ionic medium.

An embolic delivery system, comprising a drive pulley attached to adrive shaft, a timing pulley and a feeder roller attached to a pulleyshaft; a catheter or embolic agent oriented between at least two feederrollers; and, a timing belt in mechanical communication with the drivepulley and timing pulley operable to bi-directionally move the catheteror embolic agent toward a target tissue.

An embolic delivery system, comprising a drive pulley attached to adrive shaft, a timing pulley and a feeder belt attached to a pulleyshaft; a catheter or embolic agent oriented between at least two feederbelts; and, a timing belt in mechanical communication with the drivepulley and timing pulley operable to bi-directionally move the catheteror embolic agent toward a target tissue.

The apparatus as above wherein at least one feeder roller includes agroove around its circumference to assist in feeding and providingtraction between the feeder roller and the catheter or embolic agent.

An embolic delivery system, comprising a rotatable cylinder with atleast one feeder chute is on the surface of the cylinder with an inletport for accepting an embolic agent; and, a concentric wall opposing thecylinder surface operable to retain the embolic agent inside the feederchute as the cylinder is rotated.

A method for implanting an embolic agent, comprising inserting anembolic agent securably linked to a detachment element into anintroducer catheter; propelling the embolic agent to the target tissue;and, detaching the embolic agent at the target tissue. The method asabove further comprising securing a pusher element and the embolic agentwith a traction element. The method as above further comprisingpropelling the embolic agent with a mechanical embolic delivery system.The method as above further comprising propelling the embolic agent witha hydraulic embolic delivery system. The method as above of furthercomprising modifying the embolic agent with an embolic detachment tool.The method as above wherein the embolic detachment tool is selected fromthe group consisting of a spark generator, a heat gun, a sander, ashaper, a wire stripper, a dissolution chamber, a swage tool, anadhesive, a heat chamber, a scissor or a blade.

An embolic delivery apparatus, comprising a cylindrical piston operableto push an embolic agent along a track; a trolley in mechanicalcommunication with the piston via a rack, a pinion, a pinion shaft, areel, a tether, a tether guide, a clutch, a clutch arm, a spring and aspring mount operable to translate the bi-directional motion of thetrolley by the operator's hand movement.

An embolic agent apparatus, comprising a non-segmented variable lengthembolic agent with a proximal end, a middle portion, and a distal end;and, at least one detachment element located continuously along thelength of the embolic agent at which the operator may select thedetachment site at any location along the length of the embolic agent.

An embolic agent apparatus, comprising a thermally reactive wireincorporated into an embolic agent wherein the thermal wire includesshape memory such that the embolic agent is substantially linear in theextracorporeal environment and upon introduction into the intracorporealenvironment at elevated temperature the embolic agent assumes a complexmemory shape. An embolic delivery apparatus, comprising a cam gripperproviding a grip around the circumference of the embolic agent in theforward linear direction for advancement of the embolic agent andreleasing the grip on the embolic agent when the cam gripper is movingin the opposite linear direction. An embolic agent apparatus, comprisingan embolic agent with a distal end, a middle portion, and a proximalend, including a larger surface contact area on the proximal end and thedistal end of the embolic agent providing for axial movement of theembolic agent.

While the invention has been particularly shown and described withreference to a various embodiments, it will be understood by thoseskilled in the art that various changes in form and detail may be madetherein without departing from the spirit and scope of the invention.

I claim:
 1. An embolic agent apparatus, comprising: an embolic agentwith at least two or more segments, each segment of the embolic agenthaving a proximal end, a middle portion, and a distal end; and, adetachment element separating each embolic agent segment operable toprovide a detachment site selectable by the operator.
 2. The apparatusof claim 1 further comprising: a linking element operable to connect theproximal end of the embolic agent to a detachment element associatedwith the distal end of a pusher element operable to allow the operatorto orient the embolic agent with bi-directional motion.
 3. The apparatusof claim 1 further comprising: a linking element operable to link theproximal end of the embolic agent with the distal end of the detachmentelement operable to advance the detachment site of the embolic agentintracorporeally.
 4. The apparatus of claim 1 wherein the embolic agentincludes at least one node located between the distal and proximate endsof at least one segment of the embolic agent.
 5. The apparatus of claim1 wherein the embolic agent includes at least one notch located betweenthe distal and proximate ends of at least one segment of the embolicagent.
 6. The apparatus of claim 1 wherein the detachment element isselected from the group consisting of a mechanical detachment element,an electrolytic detachment element, a bi-directional locking element, aheat sensitive adhesive, a heat deformable metal, a corrodible metal, adissolvable metal, and a dissolvable polymer.
 7. The apparatus of claim1 wherein the embolic agent is selected from the group consisting of amonofilament, a multifilament, a helical wire, an encapsulated wire, acoated helical wire, a chemically dissolvable polymer, anelectrolytically corrodible wire, a polymer, a metal wire, apolyglycolide, a polylactide, a poly L-lactide, a poly DL-lactide, apoly-caprolactone, and a copolymer.
 8. The apparatus of claim 1 whereinat least one segment of the embolic agent includes a removable seal. 9.The apparatus of claim 1 wherein the embolic agent further comprises: awire within the body of the embolic agent capable of conductingelectrical current.
 10. The apparatus of claim 1 wherein the embolicagent further comprises: a traction element located on a surface of theembolic agent.
 11. The apparatus of claim 1 further comprising: alinking element with an attachment pin and the linking elementpositioned between the embolic agent and the detachment element.
 12. Theapparatus of claim 11 wherein the linking element includes a tractionelement applied to the attachment pin wherein the traction element isselected from the group consisting of a barb, a ridge, an attachmentpin, a curved attachment pin, a frictional roughness, and a threadedconnection.
 13. The apparatus of claim 1 wherein the detachment elementis one selected from the group consisting of an adhesive, a sealant, achemically corrodible polymer, an electrolytically corrodible metal, apolymer, polyglycolide, a polylactide, a poly L-lactide, a polyDL-lactide, a poly-caprolactone, and a copolymer.
 14. The apparatus ofclaim 1 wherein the detachment element or embolic agent is modified byan embolic detachment tool selected from the group consisting of a sparkgenerator, a heat gun, a sander, a shaper, a wire stripper, adissolution chamber, a swage tool, an adhesive, a heat chamber, ascissor or a blade.
 15. The apparatus of claim 1 wherein the comprising:a catheter for guiding the embolic agent to the target tissue whereinthe catheter includes an electrical current conducting wire securedwithin the wall of the catheter up to the catheter tip, operable toallow the operator to place the tip of the catheter at the desireddetachment element and electrolytically detach the embolic agentintracorporeally.
 16. The apparatus of claim 1 wherein the comprising: acatheter for guiding the embolic agent to the target tissue wherein thecatheter delivers a solvent to the selected detachment element, operableto allow the operator to place the tip of the catheter at the desireddetachment element and chemically detach the embolic agentintracorporeally.
 17. The apparatus of claim 1, wherein the embolicagent further comprises a thermally reactive wire incorporated into theembolic agent wherein the thermal wire includes shape memory such thatthe embolic agent is substantially linear in the extracorporealenvironment and upon introduction into the intracorporeal environment atelevated temperature the embolic agent assumes a complex memory shape.18. A catheter apparatus, comprising: a lumen and a wall forming a tubestructure with a proximal end, a middle portion and a distal end; atleast one wire encapsulated within the wall portion capable ofconducting electricity; and, a contact attached to the proximal end ofthe tube and a contact attached to the distal end of the tube so as toprovide electrical energy to an embolic agent, a detachment element orthe local ionic medium.
 19. An embolic delivery system, comprising: adrive pulley attached to a drive shaft, a timing pulley and a feederroller attached to a pulley shaft; a catheter or embolic agent orientedbetween at least two feeder rollers; and, a timing belt in mechanicalcommunication with the drive pulley and timing pulley operable tobi-directionally move the embolic agent toward a target tissue.
 20. Theapparatus of claim 19 wherein at least one feeder roller includes agroove around its circumference to assist in feeding and providingtraction between the feeder roller and the catheter or embolic agent.